Device based risk management of a therapeutic

ABSTRACT

A risk management system (RMS) device includes a RMS database and a RMS processor. The RMS processor includes a prescriber module to receive a request to enroll a patient in a RMS program of a therapeutic agent associated with multiple indications. The request includes a specification of at least one indication, and a confirmation of a diagnostic test conducted on the patient. The RMS processor also includes a patient module configured to generate a patient profile. The RMS processor also includes a database module configured to store the patient profile in the RMS database. The RMS processor also includes an authorization module configured to generate an authorization code indicating whether the patient is authorized to receive the therapeutic agent. The RMS processor also includes a communication module configured to transmit the authorization code to a pharmacy or a prescriber.

PRIORITY TO RELATED APPLICATION

This application claims priority to and is a continuation of PCTApplication No. PCT/US2015/013491 titled “DEVICE-BASED RISK MANAGEMENTOF A THERAPEUTIC” filed Jan. 29, 2015, which claims priority to U.S.provisional application No. 61/932,985 titled “SYSTEMS, APPARATUSES, ANDMETHODS FOR RISK MANAGEMENT OF A THERAPEUTIC” filed Jan. 29, 2014, thedisclosures of each of which are incorporated herein by reference intheir entirety.

BACKGROUND

Therapeutics such as medications have the potential to considerablyimprove the health and well-being of patients, but medication use is notwithout risk, particularly in unmonitored, out-patient settings. Despiteincreasing risk mitigation activities and risk communications fromregulatory bodies such as the Food and Drug Administration (FDA),several medications with known, preventable risks have been withdrawnfrom the market or placed on restricted distribution because of a lackof appropriate patient monitoring. In other cases, medications continueto be inappropriately prescribed to patients who have contraindicationsto a medication's use that manifest once the patient starts using themedication.

Thus, there exists a need for effective device-based risk management oftherapeutics having known contraindications and/or side effects.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of a system including a RMS hostdevice, according to an embodiment.

FIG. 2 is a flow chart illustrating a method of the RMS host device ofFIG. 1, according to an embodiment.

FIG. 3 is a flow chart illustrating a method of the RMS host device ofFIG. 1, according to another embodiment.

FIG. 4 is a flow chart illustrating a method of the RMS host device ofFIG. 1, according to an embodiment.

FIG. 5 is a flow chart illustrating a method of the RMS host device ofFIG. 1, according to an embodiment.

FIG. 6 is a flow chart illustrating a method of the RMS host device ofFIG. 1, according to an embodiment.

FIGS. 7A-7E are examples of information flow between the variousentities illustrated in FIG. 1.

FIG. 8 is a flow chart illustrating a method of the RMS host device ofFIG. 1, according to an embodiment.

FIG. 9 is a flow chart illustrating a method of the RMS host device ofFIG. 1, according to an embodiment.

FIG. 10 is a flow chart illustrating a method of the RMS host device ofFIG. 1, according to an embodiment.

SUMMARY

A risk management system (RMS) device includes a RMS database and a RMSprocessor. The RMS processor includes a prescriber module to receive arequest to enroll a patient in a RMS program of a therapeutic agentassociated with multiple indications. The request includes aspecification of at least one indication, and a confirmation of adiagnostic test conducted on the patient. The RMS processor alsoincludes a patient module configured to generate a patient profile. TheRMS processor also includes a database module configured to store thepatient profile in the RMS database. The RMS processor also includes anauthorization module configured to generate an authorization codeindicating whether the patient is authorized to receive the therapeuticagent. The RMS processor also includes a communication module configuredto transmit the authorization code to a pharmacy or a prescriber.

DETAILED DESCRIPTION

Systems, devices and methods are described herein that enable managementof risk of use of one or more therapeutic agents, such as prescriptiondrugs (i.e., the restricted items) and potential side effects (risk)associated therewith. Aspects of the disclosure enable various entitiesinvolved in risk management, such as drug manufacturers, prescribers(e.g., medical professionals), patients, and dispensing entities (e.g.,a hospital, an out-patient pharmacy, and/or the like) to interact in amanner that permits safe and informed use of a restricteddrug/therapeutic agent, while mitigating known and unknown safety risksassociated with the therapeutic agent.

In some embodiments, a risk management system (RMS) device includes aRMS database and a RMS processor. The term “RMS” or “risk managementsystem” can represent any system that implements a management and/ordistribution strategy for a therapeutic, such as a drug and/or abiological product, and can encompass scenarios in which such systemsare mandated and/or desired by an entity in the supply/distributionchain (e.g., a manufacturer) of the therapeutic and/or a regulatory body(e.g., the United States' Food and Drug Administration (FDA)). Forexample, one such RMS can be used to implement a Risk Evaluation andMitigation Strategy (REMS) that can be required if the FDA determinesthat a REMS is necessary to ensure the benefits of the therapeuticoutweigh its risks. As another example, an RMS can encompass the riskmanagement practices required by the European Medicines Agency relatingto the post authorization follow-up of efficacy and adverse reactionsfor advanced therapy medicinal products. As yet another example, an RMScan encompass risk management guidelines of the Japanese Ministry ofHealth, Labor, and Welfare (MHLW)/Pharmaceutical and Medical DevicesAgency (PMDA). In other embodiments, a RMS device can be initiatedand/or implemented without being required by a regulatory body (e.g., bya manufacturer and/or distributor on a voluntary basis to mitigaterisk).

The RMS processor includes a prescriber module configured to receive,via a communication network and from a compute device associated with aprescriber, a request to enroll a patient in a RMS program of atherapeutic agent associated with multiple indications. The requestincludes a specification of at least one indication, and a confirmationof a diagnostic test conducted on the patient. The diagnostic test isassociated with the therapeutic agent and associated with theindication. The RMS processor also includes a patient module incommunication with the prescriber module. The patient module isconfigured to generate in response to the request a patient profile byidentifying a predetermined enrollment period based on the indication.The predetermined enrollment period can have a first duration when theindication is a first indication. The predetermined enrollment periodcan have a second duration different from the first duration when theindication is a second indication. The RMS processor also includes adatabase module in communication with the RMS database. The databasemodule is configured to store the patient profile in the RMS database.The RMS processor also includes an authorization module configured to,based on the predetermined enrollment period, generate an authorizationcode indicating whether the patient is authorized to receive thetherapeutic agent. The RMS processor also includes a communicationmodule configured to transmit via the communication network theauthorization code to at least one of a compute device associated with apharmacy or the compute device associated with a prescriber.

In some embodiments, a RMS device includes a RMS database storingdispenser profiles, patient profiles, and prescriber profiles. The RMSdevice also includes a RMS processor. The RMS processor can include adispenser module configured to receive, for a therapeutic agentassociated with at least one indication, a request from a compute deviceassociated with a pharmacy to dispense a first quantity of thetherapeutic agent to a patient. The RMS database can include a dispenserprofile for the pharmacy and the RMS database can include a patientprofile for the patient. The RMS processor can also include a prescribermodule configured to receive a confirmation of a successful diagnostictest of the patient from a compute device associated with a prescriber.The RMS database can include a prescriber profile for the prescriber.The RMS processor can also includes an authorization module configuredto generate a first authorization code if the confirmation of thesuccessful diagnostic test of the patient was received within a firstpredetermined time period. The authorization module can be furtherconfigured to generate a second authorization code if at least one ofthe following is true: (1) the confirmation of the successful diagnostictest of the patient is not received within the first predetermined timeperiod, and the request from the compute device associated with thepharmacy is received within a second predetermined time period; or (2) arequest is received from the compute device associated with theprescriber to dispense a second quantity of the therapeutic agent to thepatient and different from the first quantity. The RMS processor canalso include a communication module for transmitting the firstauthorization code or the second authorization code to the computedevice associated with the pharmacy.

Aspects of the systems, devices, and methods described herein arefurther operable to ensure that prescribers are certified to prescribethe therapeutic agent via testing. In some embodiments, a methodincludes receiving, at a host device of a RMS system for a therapeuticagent associated with at least one indication, from a prescriber, arequest to enroll the prescriber in the RMS. The method further includesproviding, to the prescriber, educational material associated with theRMS and associated with the therapeutic agent. The method additionallyincludes providing, to the prescriber, access to a test relating to theeducational material, and receiving, at the host device, an identifierof a performance of the prescriber on the test. The method also includesenrolling, at the host device, the prescriber in the RMS if theperformance of the prescriber meets a performance criterion for thetest.

Aspects of the systems, devices, and methods described herein arefurther operable to ensure that dispensers such as pharmacies arecertified to dispense the therapeutic agent via testing. In someembodiments, a method includes receiving, at a host device of the RMSfor a therapeutic agent associated with at least one indication, from apharmacy, a request to enroll the pharmacy in the RMS. The method alsoincludes providing, to a pharmacist associated with the pharmacy,educational material associated with the RMS and with the therapeuticagent, and further includes providing, to the pharmacist, access to atest relating to the educational material. An identifier of aperformance of the pharmacist on the test can be received at the hostdevice, and the pharmacy can be enrolled at the host device in the RMSif the performance of the pharmacist meets a performance criterion forthe test.

Aspects of the systems, devices, and methods described herein arefurther operable to ensure that the patient receives the therapeuticagent and/or a refill of the therapeutic agent upon confirmation of thepatient undergoing a diagnostic test required to receive the therapeuticagent and/or a refill of the therapeutic agent. In some embodiments, amethod includes receiving, at a host device of the RMS for a therapeuticagent associated with at least one indication, a confirmation of adiagnostic test of a patient enrolled in the RMS by a prescriberenrolled with the RMS. The method also includes, based on the receipt ofthe confirmation by the prescriber, generating an authorization codeindicating whether a pharmacy enrolled in the RMS is authorized todispense the therapeutic agent to the patient. A request to dispense thetherapeutic agent to the patient is received at the host device and froma compute device associated with the pharmacy. The authorization codecan be provided to the compute device associated with the pharmacy.

Aspects of the systems, devices, and methods described herein arefurther operable to ensure that a patient can still avail of thetherapeutic agent, albeit to a limited extent and/or under specificcircumstances, if the confirmation of the diagnostic test is notreceived at the time the patient provides a prescription for thetherapeutic agent to the dispenser/pharmacy. In some embodiments, amethod includes receiving, at a host device of the RMS, for atherapeutic agent associated with at least one indication, a requestfrom a compute device associated with a pharmacy enrolled in the RMS todispense a first quantity of the therapeutic agent to a patient enrolledin the RMS. The method includes generating a first authorization code ifa confirmation of a successful diagnostic test of the patient wasreceived from a prescriber enrolled in the RMS within a firstpredetermined time period. A second authorization code is generated ifat least one of the following is true: (1) the confirmation of thesuccessful diagnostic test of the patient is not received within thefirst predetermined time period, and the request from the compute deviceassociated with the pharmacy is received within a second predeterminedtime period; or (2) a request is received from a compute deviceassociated with the prescriber to dispense a second quantity of thetherapeutic agent to the patient and different from the first quantity.The method further includes generating a third authorization code if theconfirmation of the successful diagnostic test of the patient was notreceived within the first predetermined time period and if the requestfrom the compute device associated with the prescriber to dispense thesecond quantity of the therapeutic agent is not received. The firstauthorization code, the second authorization code, or the thirdauthorization code is provided to the compute device associated with thepharmacy.

Aspects of the systems, devices, and methods described herein arefurther operable for multiple indications. At least some of the multipleindications can be associated with different enrollment periods for apatient. In some embodiments, a method includes receiving, at a hostdevice of a RMS for a therapeutic agent associated with multipleindications and from a prescriber, a request to enroll a patient in theRMS. The request can include a specification of an indication and canfurther include a confirmation of a diagnostic test conducted on thepatient. The diagnostic test is associated with the therapeutic agentand the indication. The method also includes enrolling, at the hostdevice, in response to the request, the patient in the RMS. Theenrolling can include identifying a predetermined enrollment periodbased on the indication. The predetermined enrollment period can have afirst duration when the indication is a first indication from themultiple indications. The predetermined enrollment period can have asecond duration different from the first duration when the indication isa second indication from the multiple indications. The method alsoincludes generating, based on the predetermined enrollment period, anauthorization code indicating whether the patient is authorized toreceive the therapeutic agent.

Aspects of the systems, devices, and methods described herein arefurther operable to ensure that a patient is enrolled in the RMS for thecorrect indication (from multiple indications associated with atherapeutic agent) and duration, prior to dispensing the therapeuticagent to the patient for the indication. In some embodiments, a methodincludes receiving, at a host device of a RMS for a therapeutic agentassociated with multiple indications and from a compute deviceassociated with a pharmacy enrolled in the RMS, a request to dispense aquantity of the therapeutic agent to a patient not enrolled in the RMS.The request can include a specification of an indication. If the requestmeets a patient enrollment criterion associated with the indication, afirst authorization code can be generated, and the patient can beenrolled in the RMS for a first duration at the host device and inresponse to the request. If the indication is a second indication andthe request meets a patient enrollment criterion associated with thesecond indication, a second authorization code can be generated, and thepatient can be enrolled in the RMS for a second duration different fromthe first duration at the host device and in response to the request.The method can also include providing the first authorization code orthe second authorization code to the compute device associated with thepharmacy.

In some embodiments, a method includes receiving, at a host device of aRMS for a therapeutic agent associated with multiple indications andfrom a prescriber, a request to enroll a patient in the RMS. The requestcan include a specification of an indication and can further include aconfirmation of a diagnostic test conducted on the patient. Thediagnostic test can be associated with the therapeutic agent and theindication. The method can also include enrolling, at the host device,in response to the request, the patient in the RMS. The enrolling caninclude identifying a predetermined enrollment period based on theindication. The predetermined enrollment period can have a firstduration when the indication is a first indication. The predeterminedenrollment period can have a second duration different from the firstduration when the indication is a second indication. The method can alsoinclude generating, based on the predetermined enrollment period, anauthorization code indicating whether the patient is authorized toreceive the therapeutic agent.

Aspects of the systems, devices, and methods described herein arefurther operable to ensure that a patient enrolled in the RMS for one ofseveral indications associated with a therapeutic agent can, in someembodiments, continue to receive the therapeutic agent even if thepatient does not meet a dispensation criterion (e.g., confirmation of adiagnostic test) for the indication/therapeutic agent, but does meet adispensation criterion for another of the indications. In someembodiments, a method includes receiving, at a host device of a RMS, fora therapeutic agent associated with multiple indications, a request froma compute device associated with a pharmacy enrolled in the RMS todispense the therapeutic agent to a patient enrolled in the RMS. Therequest can include an identifier of a first indication. The method canalso include generating, at the host device, an authorization codeassociated with the patient if: (1) the request does not meet adispensation criterion associated with the first indication and (2) therequest meets a dispensation criterion associated with a secondindication. The method can also include providing the authorization codeto the compute device associated with the pharmacy such that thepharmacy can use the authorization code to dispense the therapeuticagent to the patient.

Aspects of the systems, devices, and methods described herein arefurther operable to ensure that a patient is enrolled in the RMS for thecorrect indication as well as to ensure that the patient has requested(and receives) a correct form of the therapeutic agent (e.g., a correctquantity, dosage, frequency, strength, number of tablets, type ofmedication (tablets, liquid, capsule, etc.) etc.). In some embodiments,a method includes receiving, at a host device of a RMS for a therapeuticagent associated with multiple indications and from a compute deviceassociated with a pharmacy enrolled in the RMS, a request to dispense aquantity of the therapeutic agent to a patient not enrolled in the RMS.The request can include a specification of an indication. If (1) theindication is a first indication, (2) the request meets a patientenrollment criterion associated with the first indication, and (3) thequantity meets a dispensation criterion associated with the therapeuticagent for the first indication, the host device can generate a firstauthorization code, and can enroll in response to the request, thepatient in the RMS for a first duration. If (1) the indication is asecond indication, (2) the request meets a patient enrollment criterionassociated with the second indication, and (3) the quantity meets adispensation criterion associated with the therapeutic agent for thesecond indication, the host device can generate a second authorizationcode, and can enroll, in response to the request, the patient in the RMSfor a second duration different than the first duration. The method canfurther include providing the first authorization code or the secondauthorization code to the compute device associated with the pharmacy.In some embodiments, enrolling a patient in a RMS can include, forexample, activating a previous enrollment, re-enrolling the patient inthe RMS, extending a duration of an enrollment period for a patient inthe RMS, and/or the like.

As used in this specification, the singular forms “a,” “an” and “the”include plural referents unless the context clearly dictates otherwise.Thus, for example, the term “a network” is intended to mean a singlenetwork or a combination of networks.

FIG. 1 is a schematic illustration of a system within which aspects of aRMS host device 100 (hereon “host device”) can be implemented andemployed for one or more therapeutic agents, and for one or moreindications. The host device 100 is operable for use by entities(illustrated in FIG. 1 in singular, for simplicity) such as one or moreprescribers 112, one or more patients 114, and one or more dispensers116 for risk management of one or more therapeutic agents. In someembodiments, the host device 100 is owned by, managed by, and/orotherwise associated with one or more manufacturers and/or distributorsof the one or more therapeutic agents; in other words, any entity in thebusiness-to-business distribution chain, not including the last entitythat is involved in the business-to-patient dispensing of the one ormore therapeutic agents.

It is understood that the prescriber 112, the patient 114, and/or thedispenser 116 can represent human entities, hardware/software interfaces(e.g., a compute device, a land or mobile phone, a web interface, and/orthe like) interacting with the host device 100, and/or the like. Forexample, the prescriber 112 can encompass a web browser-based interfaceand/or a cloud-based application for administering a certification testto the prescriber (described later), an office phone of the prescriberfor requesting diagnostic test confirmation (described later), and/orthe like. In another example, the dispenser 116 can encompass a webbrowser-based interface for providing codes (described later) to thedispenser for dispensing the therapeutic agent(s) to the patient 114. Inthis manner, the distinction between these entities, and particularlybetween the prescriber 112 and the dispenser 116, can be simplyfunctional; said another way, it is conceivable that the same entity canboth prescribe and dispense the drug, but would interact with the hostdevice 100 via different interfaces.

The host device 100 can be in communication with the prescriber 112, thepatient 114, and/or the dispenser 116 as indicated by solid lines inFIG. 1 via, for example, one or more networks, each of which can be anytype of network such as, for example, a local area network (LAN), a widearea network (WAN), a virtual network, a telecommunications network,and/or the Internet, implemented as a wired network and/or a wirelessnetwork. Any or all communications can be secured (e.g., encrypted) orunsecured, as is known in the art. The host device 100 can be a personalcomputer, a server, a work station, a tablet, a mobile device, a cloudcomputing environment, an application or a module running on any ofthese platforms, and/or the like. The dotted lines indicatecommunications and/or other interactions between the prescriber 112, thepatient 114, and/or the dispenser 116 that do not necessarily take placevia the host device 100 such as, for example, a prescriber 112 callingin a prescription to the dispenser 116 over a telephone for the patient114.

The host device 100 includes at least a processor 110 (also sometimesreferred to as a “RMS processor”) and a memory 160. FIG. 1 alsoillustrates a database 170 (also sometimes referred to as a “RMSdatabase”), although it will be understood that, in some embodiments,the database 170 and the memory 160 can be a common data store. In someembodiments, the database 170 constitutes one or more databases.Further, in other embodiments (not shown), at least one database can beexternal to the host device 100. FIG. 1 also illustrates an input/output(I/O) component 180, which can depict one or more input/outputinterfaces, implemented in software and/or hardware, for the prescriber112, the patient 114, the dispenser 116, and/or other entities tointeract directly or indirectly with the host device 100.

The memory 160 and/or the database 170 can independently be, forexample, a random access memory (RAM), a memory buffer, a hard drive, adatabase, an erasable programmable read-only memory (EPROM), anelectrically erasable read-only memory (EEPROM), a read-only memory(ROM), Flash memory, and/or so forth. The memory 160 and/or the database170 can store instructions to cause the processor 110 to executemodules, processes and/or functions associated with the host device 100.

The processor 110 includes a business module 122, a prescriber module124, a patient module 126, a dispenser module 128, an authorizationmodule 130, a database module 136, and a communication module 140. Insome embodiments, the processor 110 can include additional modules (notshown). Each module can independently be a hardware module and/or asoftware module (implemented in hardware, such as the processor 110).

In some embodiments, the functionality of one or more of the modules canbe combined and/or overlap. For example, the communication module 140and the database module 140 can be a single module. In some embodiments,the functionality of one or more modules and/or the interaction betweenthe modules can be based on regulatory requirements for data processing,storage, integrity, security, and/or the like.

The processor 110 can be, for example, a general purpose processor, aField Programmable Gate Array (FPGA), an Application Specific IntegratedCircuit (ASIC), a Digital Signal Processor (DSP), and/or the like. Theprocessor 110 can be configured to run and/or execute applicationprocesses and/or other modules, processes and/or functions associatedwith the device 100 and/or the network. Any of the prescriber 112, thepatient 114, the dispenser 116 can also includes a memory and aprocessor (not shown in FIG. 1).

The communication module 140 can be operable to facilitate networkconnectivity for the host device 100 as is known in the art. Forexample, the communication module 140 can include and/or enable anetwork interface controller (NIC), wireless connection, a wired port,and/or the like. As such, the communication module 140 can establishand/or maintain a communication session with the prescriber 112, thepatient 114 and/or the dispenser 116. Similarly stated, thecommunication module 140 can enable the RMS host device 110 to send datato and/or receive data from the prescriber 112, the patient 114 and/orthe dispenser 116.

The database module 136 is operable for interfacing with the memory 160and/or the database 170 for data manipulation (including storage,modification, and/or deletion). For example, the database module 136 canbe operable for storing a prescriber profile of the prescriber 112 inthe memory 160, for storing a patient profile of the patient 114 in thedatabase 170, and/or the like. In another example, the database module136 can be operable for storing a patient profile in the database 170and/or modifying a patient profile stored in the database 170 to changethe patient's status from active to inactive (described in furtherdetail herein). In yet another example, the database module 136 can beoperable to delete or update (e.g., set an inactive flag) a dispenserprofile associated with the dispenser 116 and stored in the database 170when the dispenser fails to reenroll with the host device 100 beforeexpiration of a dispenser enrollment period.

The business module 122 is operable to facilitate control of the hostdevice 100, including viewing and manipulating the memory 160 and/or thedatabase 170. In some embodiments, and as will be described in moredetail herein, the business module 122 can be further operable tofacilitate entry of information by a user (not shown), such as atelephone operator, a third party compute device, and/or the like,associated with the host device 100, where the user in turn interactswith the prescriber 112, the patient 114, and/or the dispenser 116.

In some embodiments, the prescriber module 124 is operable to enroll theprescriber 112 with the host device 100 for one or more of thetherapeutic agents. In some embodiments, the one or more therapeuticagents includeN-(4-{[(5R)-7-chloro-5-hydroxy-2,3,4,5-tetrahydro-1H-1-benzazepin-1-yl]carbonyl}-3-methylphenyl)-2-methylbenzamide,or tolvaptan (“tolvaptan” hereon). In some embodiments, the one or moretherapeutic agents include different formulations and/or uses oftolvaptan. In some embodiments, the different formulations and/or usesof tolvaptan are directed to different indications. In some embodiments,at least one of the indications is hyponatremia. In some embodiments, atleast one of the indications is autosomal dominant polycystic kidneydisease (ADPKD).

In some embodiments, the prescriber module 124 is operable to directlyreceive a request from the prescriber 112 to be enrolled via anysuitable means, such as, for example, via a web interface of theprescriber module 124. In other embodiments, the prescriber module 124receives a request to enroll the prescriber 112 indirectly. For example,in some embodiments, the prescriber 112 provides an enrollment requestvia a mail-in form, a facsimile form, or via a telephone call. In suchembodiments, the enrollment request can be entered into the host device100 via the business module 122 (e.g., by a user interacting directlywith the host device), and subsequently and/or indirectly be received bythe prescriber module 124.

In some embodiments, the enrollment request includes prescriberenrollment information. In some embodiments, the prescriber enrollmentinformation is received as part of an enrollment form reviewed andcompleted by the prescriber 112. In some embodiments, an emptyprescriber enrollment form is provided to the prescriber 112 in responseto the enrollment request, and the enrollment information/completedenrollment form is received in response to the empty enrollment formbeing provided. In some embodiments, the enrollment request is specificfor one or more therapeutic agents and/or indications, and subsequentenrollment activity is directed towards enrolling the prescriber 112with the host device 100 for the specific therapeutic agent(s) and/orindication(s).

Explained hereon with respect to one specific therapeutic agent forsimplicity, in some embodiments, in response to an enrollment requestfor a therapeutic agent, the prescriber module 124 is operable toprovide educational information and certification information to theprescriber 112, such as via a web interface, email, and/or the like. Inother embodiments, a user of the device 100 is prompted (via thebusiness module 122) to provide printed education information andcertification information to the prescriber 112, such as, for example,via postal mail, or via facsimile.

In some embodiments, the educational information includes one or more ofthe following: prescription information for the therapeutic agent,prescriber compliance requirements for enrollment, one or moreindications associated with the therapeutic agent, one or more sideeffects associated with the therapeutic agent, adverse event reportinginformation for the therapeutic agent (whether associated with the oneor more indications or otherwise), a listing of additional educationalresources, diagnostic testing requirements for patients enrolled in theRMS system, and/or the like. The prescription information can include,but is not limited to, patient enrollment/discontinuation information,patient counseling information, diagnostic test ordering information,diagnostic test reviewing information, diagnostic testreporting/confirmation information, patient re-enrollment information,and/or the like. In some embodiments, the educational information is inthe form of a letter, an online form, an email message, an interactive(online or in-person) question and answer session, and/or the like. Inembodiments where the enrollment request specifies two or moretherapeutic agents, the educational information can encompass thespecified therapeutic agents.

The certification information can include access information for acertification test that is related to the educational information. Insome embodiments, the access information includes a unique link and/oridentifier for accessing a web-based certification test that isconducted by the prescriber module 122. In some embodiments, athird-party can administer the prescriber certification test, eitherdirectly via the host device 100 or indirectly (not shown) from a serverand/or host device associated with the third-party. In otherembodiments, the third-party can manually administer the test (e.g., ata testing center, at the prescriber's office, etc.).

In other embodiments, the access information includes a telephone numberwhere the prescriber 112 can call in and take a phone-based automated ormanually administered certification test. In some embodiments, theaccess information is a fillable request (e.g., a prepaid postcard) fora paper copy of the certification test to be mailed to the prescriber112. In some embodiments, the certification information can include thecertification test. In some embodiments, the duration of enrollment ofthe prescriber 112 is based on the performance of the prescriber (e.g.,a higher score results in a greater duration of enrollment than a lowerscore, and vice versa). For example, if the prescriber's score is abovea first threshold but below a second threshold, the prescriber can beauthorized to prescribe the therapeutic agent for a first time period.If, however, the prescriber's score is above both the first thresholdand the second threshold, the prescriber can be authorized to prescribethe therapeutic agent for a second time period greater than the firsttime period.

The certification test can includes questions in any suitable format(e.g., multiple choice questions, short answers, and/or the like) thattest the prescriber's ability to understand the educational information.In some embodiments, the prescriber module 122 is operable to whollyanalyze the performance of the prescriber 112 on the certification test(e.g., responses to multiple choice questions, via automated textualanalysis, and/or the like). In other embodiments, the prescriber module124 analyzes a portion of the certification test, and receives ananalysis of a remainder portion of the certification test from anotherentity (e.g., an external testing entity, a user of the device 100,and/or the like). In yet another embodiment, the prescriber module 124communicates the prescriber's responses to the certification test toanother entity that analyzes the responses (not shown).

In some embodiments, analysis of the certification test yields anidentifier of the performance of the prescriber 112. In someembodiments, the identifier is a sliding scale (e.g., 43% correct,56/100 correct, and/or the like) or a discrete scale (e.g., 30-40%correct, 50-60 correct, and/or the like) measure of the performance ofthe prescriber 112. In some embodiments, the identifier is a binaryidentifier of the performance of the prescriber 112 such as, forexample, whether the prescriber achieved a threshold score (“pass”) ornot (“fail”). In some embodiments, the threshold score can be a perfectscore (i.e., 100% correct). In some embodiments, the certification testincludes several sections, and the identifier can be a combination ofidentifiers for each section, or a single identifier across multiplesections.

In some embodiments, the prescriber module 124 is operable to enroll theprescriber 112 in the host device 100 if the performance of theprescriber meets a performance criterion for the certification test. Theperformance criterion for the certification test, or for a sectionthereof, can be one or more of the following: a threshold measure (e.g.,at least 60%), a binary measure (e.g., must achieve a “pass” score, asdiscussed above), and/or the like.

In some embodiments, enrolling the prescriber includes providing theprescriber enrollment form to the prescriber 112 via the prescribermodule 112, and/or receiving the completed enrollment form from theprescriber, either directly or indirectly via the prescriber module 112.The enrollment form can include fields for one or more of the following:the prescriber's name, a registration identifier for the prescriber suchas a national provider identifier NPI), contact information,credentials, specialty, consent to a contractual agreement provided forin the enrollment form, and/or the like.

In some embodiments, the prescriber module 124 is further operable to,in response to receiving the enrollment form, generate a certificationidentifier for the prescriber 112. The prescriber module 124 is furtheroperable to generate a prescriber profile for the prescriber 112, and tostore the prescriber profile in the memory 160 and/or the database 170(e.g., via the database module 136). The prescriber profile can include,but is not limited to, the prescriber enrollment information, thecertification identifier, the therapeutic agent(s) and/or indication(s)for which the prescriber 112 is enrolled, a duration of enrollment ofthe prescriber for each therapeutic agent, a date of the last passedcertification test, and/or the like.

Although described herein with respect to embodiments where theprescriber 112 requests to be enrolled, in other embodiments, theprescriber module 124 is operable to invite the prescriber to enroll byproviding to the prescriber, without any input from the prescriber, theeducational information and the certification information. Theprescriber 112 can then take the certification test and be enrolled in amanner similar to as described above.

In some embodiments, the enrollment of the prescriber 112 with the RMSdoes not expire within a specific time period. In some embodiments, theenrollment of the prescriber 112 with the RMS expires at the end of aprescriber enrollment period, and the prescriber module 124 is operableto remind the prescriber to re-enroll when the prescriber's enrollmentperiod is about expire. The prescriber 112 can then opt to re-enrollprior to expiration. In some embodiments, the prescriber 112 is requiredto re-take the certification test and/or take a different certificationtest for re-enrollment, while in other embodiments, prescriberre-enrollment does not require completing an assessment.

In some embodiments, the patient module 126 is operable to receive, viaa communication network and from the prescriber 112 or a compute deviceassociated with a prescriber 112, a request to enroll a patient in a RMSprogram of a therapeutic agent associated with multiple indications. Therequest can include a specification of at least one indication. In someembodiments, the request can also include a confirmation of a diagnostictest conducted on the patient, where the diagnostic test is associatedwith the therapeutic agent and with the indication. In some embodiments,the patient module 126 is operable to enroll the patient 114 with thehost device 100 for one or more of the therapeutic agents and/or for oneor more indications. In some embodiments, the patient module 126 isoperable to provide a patient enrollment form to the patient 114 and/orthe prescriber 112, and to receive patient enrollment information fromthe patient 114 and/or the prescriber 112.

In some embodiments, the patient module 126 is operable to provide thepatient enrollment form to the prescriber 112. Said another way, in suchembodiments, the prescriber 112 enrolls the patient 114, aftercounseling the patient and obtaining the patient's consent to treatmentby the prescriber. In such embodiments, the patient module 126 isoperable to provide patient education information and the patientenrollment form to the prescriber 112, either directly or via theprescriber module 124. The prescriber 112 in turn, and in accordancewith the prescriber enrollment form described above, can communicate thepatient education information to the patient via any suitable means,including verbally, electronically, via printouts, and/or the like.Although described herein for patient enrollment, the patient enrollmentform can also be employed for patient reenrollment (e.g., each time thepatient enrollment expires).

In some embodiments, the patient enrollment form can require acertification, by the prescriber 112, of a diagnostic test conducted onthe patient 114 to monitor the potential for and/or the actualoccurrence of adverse side effects related/unrelated to the therapeuticagent(s). In such embodiments, the prescriber 112 can obtain thediagnostic test results in any suitable manner such as, but not limitedto, conducting the diagnostic test himself, ordering the diagnostic testto be conducted at a testing facility and subsequently reviewing theresults, and/or the like. In some embodiments (not detailed here), theprescriber 112 can order the diagnostic test via the host device 100,such as, for example, via an ordering module (not shown). In someembodiments, the patient 114 can choose where to be tested, and canarrange for the prescriber 112 to receive the diagnostic test results.In some embodiments, the diagnostic test is a liver function test (LFT).In some embodiments, the LFT measures plasma levels of one or more oftotal bilirubin, alanine aminotransferase, and aspartateaminotransferase.

The patient enrollment form can include patient identificationinformation, patient contact information, an indication of whether thepatient is being enrolled for the first time or reenrolled, one or moreindications for which the patient is being treated, a consent of thepatient to treatment and treatment-related issues such as diagnostictesting, one or more diagnostic test results of the patient, acertification from the prescriber that the diagnostic test results aresatisfactory, and/or the like. The patient module 126 is furtheroperable to receive the completed patient enrollment form, directly, orvia the prescriber module 124, or via the business module 122 (e.g.,when the prescriber 112 sends in a completed form via postal mail, orvia facsimile, that is subsequently entered into the device 100).

In other embodiments, the patient module 126 is operable to determine,based on the patient enrollment form or otherwise, whether the patientis a new patient (i.e., no existing patient profile), a currentlyenrolled patient (i.e., associated with an active patient profile), or apreviously enrolled patient (i.e., associated with an inactive patientprofile). In some instances, the patient 114 is a new patient, thepatient module 126 is operable to generate a new patient profile for thepatient based on the completed enrollment form, and is operable to storethe patient profile in the memory 160 and/or the database 170 (e.g., viathe database module 136). In some embodiments, the patient module 126generates the patient profile by identifying a predetermined enrollmentperiod/duration of enrollment based on the indication. The predeterminedenrollment period can have different durations for differentindications. For example, in some embodiments, the predeterminedenrollment period has a first duration for a first indication, a secondduration different from the first duration for a second indication, andso on.

The patient profile can include, but is not limited to, the patientenrollment information, the therapeutic agent(s) for which the patient114 is enrolled, prescribing information for the patient, a duration ofenrollment of the patient, one or more prescribers associated with thepatient profile, a current status of the patient profile(active/inactive), one or more indication(s) associated with thepatient, and/or the like. In some embodiments, the prescribinginformation, such as dosage, quantity, duration, number of refills, etc.is predetermined and cannot be specified by the prescriber 112.

In some instances, the patient is a currently enrolled patient having anexisting (active) patient profile, and the patient module 126 isoperable to update the existing patient profile with the information thereceived patient enrollment form. Such instances can occur, for example,when the patient is reenrolled prior to expiration of a previousenrollment period, when the patient switches to a different prescriberfor the same therapeutic, and so on.

In some instances, the patient was previously enrolled but treatment wasdiscontinued, the patient accordingly has an inactive patient profileassociated therewith, the patient module 126 is operable to update theexisting patient profile with the information from the received patientenrollment form, and to change the status of the updated patient profileto active. Such instances can occur when, for example, the patientre-continues treatment, switches from one therapeutic agent to anothertherapeutic agent that is also managed by the host device 100, receivestreatment for a different indication, and so on.

In some embodiments, the patient module 126 is further operable toreceive periodic confirmation of satisfactory diagnostic test resultsfor the patient 114 from the prescriber 112 for continued dispensing ofthe therapeutic agent. In some embodiments, a confirmation of asatisfactory diagnostic test result is required each time thetherapeutic agent is dispensed to the patient 114. In other embodiments,a confirmation of a satisfactory diagnostic test result is not requiredeach time the therapeutic agent is dispensed to the patient 114. Forexample, a confirmation of a satisfactory diagnostic test result can berequired the first time the therapeutic agent is dispensed, and then berequired for every two refills, and then be required again if/when thepatient is reenrolled. In some embodiments, the frequency at whichsatisfactory diagnostic results need be provided can be based on theindication associated with the therapeutic agent. In some embodiments,the patient module 126 is operable to store the confirmation(s) ofdiagnostic test results in the memory 160 and/or the database 170 aspart of the patient profile, or associated with the patient profile. Inother embodiments, the patient module 126 is operable to store thevalues of the diagnostic test results in the memory 160 and/or thedatabase 170 as part of the patient profile, or as associated with thepatient profile.

In some embodiments, the confirmation of satisfactory diagnostic testresults is received as a test confirmation form that is completed by theprescriber 112. The test confirmation form can include fields forpatient information, prescriber information, testing information, and/orthe like. The testing information can include test dates, acertification of the test results by the prescriber 112, a certificationby the prescriber of whether the patient should continue to receive thetherapeutic agent or not, and/or the like. In some embodiments, thetesting information can also include values of test results such as, forexample, blood levels of an analyte and/or the like. The testconfirmation form can be received electronically from the prescriber 112by the host device 100, or entered indirectly (e.g., manual entry of atest confirmation form received via postal mail, or via facsimile).

Hence, it is understood that the prescriber 112 can provide theconfirmation of the diagnostic test results to the host device 100either via the patient enrollment form, or via a separate testconfirmation form, or both. When the duration of patient enrollment issubstantially similar to the periodicity of diagnostic testing and/ordispensing, the prescriber 112 can report test results duringreenrollment via a single form. When the duration of patient enrollmentis substantially longer (e.g., a year) compared to the periodicity ofdiagnostic testing and/or dispensing (e.g., every 30 days), theprescriber 112 can personally meet with the patient 114 once a year tocomplete the patient enrollment/re-enrollment form (which can includethe signature/consent of the patient), and thereafter can submit thetest confirmation form upon reviewing the patient's diagnostic testresults, which need not include the patient's presence/consent.

In some embodiments, the duration of patient enrollment, the periodicityof the diagnostic test, the periodicity of dispensing the therapeuticagent, and/or the duration for which a prescription is provided(including refills), can each be different. As an example, theprescriber 112 can provide the confirmation of the diagnostic testresults via the patient enrollment form at the time of enrollment of thepatient 114 in the RMS for one year (or other suitable time frame). Insuch an example, the patient can receive a refill for the therapeuticagent every month after undergoing monthly diagnostic tests. In someembodiments, the duration for which a prescription is provided is threemonths (e.g., one month supply with two refills). In this example, theprescriber 112 can write a prescription for a one-month supply with tworefills and can provide confirmation of diagnostic test results whenenrolling or reenrolling (e.g., after one year or other suitabletimeframe) the patient 114. The patient 114 can receive the initialone-month supply after being enrolled in the RMS. The patient 114 canreceive each of the two refills without visiting the prescriber 112 byreceiving a diagnostic test and having the prescriber 112 confirm thediagnostic test result. In such an example, the patient 114 can visitthe prescriber 112 every three months to receive a new prescription forthree months (one-month supply with two refills). Since the duration ofpatient enrollment is one year in this example, the patient 114 can meetwith the prescriber 112 initially to be enrolled and/or reenrolled aswell as three additional times during the enrollment period.

For another example, the prescriber 112 can provide the confirmation ofdiagnostic test results via the patient enrollment form at the time ofenrollment of the patient 114 for a year. In such an example, thepatient receives a refill for the therapeutic agent every month (i.e.,11 refills), and diagnostic tests are conducted every three months. Inthis example, the prescriber 112 can order and review diagnostic testresults every three months without necessarily interacting with thepatient, and the patient 114 can receive every third refill afterproviding satisfactory diagnostic test results. For other refills, noaction is taken by the prescriber. If the prescriber decides tore-enroll the patient for another year, the prescriber can again meetwith the patient, order and review a diagnostic test, and complete thepatient re-enrollment form.

In some embodiments, the patient module 126 is further operable to issueperiodic reminders to the prescriber 112 associated with the patient 114if the test confirmation form is not received within a specified timeperiod since a previous event. The previous event can be the last timethe patient 114 received the therapeutic agent, the last time a testconfirmation form was received for the patient from the prescriber 112,and/or the like. The reminders can be issued automatically (e.g., by thehost device 100), or manually (e.g., by the dispenser 116). In someembodiments, the reminders are communicated via any suitable meansspecified by the prescriber 112 at the time of creating the prescriberprofile, such as via email, text message, an automated telephone call,an automated facsimile, a notification via a cloud-based application onthe prescriber's smart phone, and/or the like. In some embodiments, theperiodicity of the reminders and/or the determination of whether toissue a reminder or not can be based on an elapsed duration ofenrollment of the patient, a remaining duration of enrollment of thepatient, a remaining time for the specified time period, the therapeuticagent, one or more indications associated with the therapeutic agent,and/or the like. For example, if the prescriber is supposed to turn in atest confirmation form once a month, a reminder can be issued once aweek for the first two weeks since the last time a test confirmationform was turned in, twice in the third week, and every other day in thefourth week. In another example using a similar scenario, the prescriberreceives email reminders in the first two weeks, text message remindersin the third week, and automated telephone calls in the fourth week.

In some embodiments, the patient module 126 is further operable toreceive, without receiving the test confirmation form, a dispensingrequest for the therapeutic agent from the prescriber 112 for thepatient 114. In some embodiments, the dispensing request is indicativeof an authorization from the prescriber 112 for the dispenser 116 todispense a limited quantity of the therapeutic agent to the patient 114.In this manner, the prescriber 112 can authorize the dispenser 116 toprovide the therapeutic agent to the patient 114 under a number ofcircumstances such as, for example, when the patient communicates adelay in providing diagnostic test results to the provider, when theprovider has not had an opportunity to substantially review receiveddiagnostic test results, and/or the like. In some embodiments, theprescriber 112 can provide the dispensing request in response to areminder from the patient module 126 to submit the test confirmationform. In some embodiments, the prescriber 112 is permitted to issue alimited number of dispensing requests per patient enrollment period. Insome embodiments, the prescriber is not permitted to issue consecutivedispensing requests without submitting a test confirmation form inbetween.

The prescriber 112 can provide the dispensing request in any suitableform, such as via a web interface, via a reply to an email or a textmessage, via a telephone call, via facsimile, and/or the like. In someembodiments, the patient module 126 can associate a dispensing requestfor the patient 114 with the patient profile for the patient.

In some embodiments, the patient module 126 is further operable toreceive one or more adverse event reports for the patient 114 from theprescriber 112, from the patient 114, and/or from the dispenser 116. Insome embodiments, the patient module 126 is operable to store theadverse event report in the memory 160 and/or the database 170 as partof the patient profile, or as associated therewith. In some embodiments,the patient module 126 is operable to change the status of the patientprofile from active to inactive based on the adverse event report.

In some embodiments, the adverse event report is received as a completedadverse event reporting form. The adverse event reporting form caninclude fields for patient information, information about the reportingentity, and/or the like. The adverse event reporting form and/orinformation can be received electronically directly from the prescriber112 by the host device 100, or entered indirectly (e.g., manual entry).The adverse event report(s) can be stored in the memory 160 and/or thedatabase 170. In some embodiments, specific types of adverse events,such as unsatisfactory diagnostic test results, are written in adverseevent reporting form and stored in the memory 160 and/or the database170. In some embodiments, other types of adverse events can be reporteddirectly to manufacturer(s) of the therapeutic agent(s).

In some embodiments, the stored adverse event reports are searchable bythe prescriber 112, the patient 114, the dispenser 116 and/or otherentities (not shown) such as researchers, regulatory bodies, otherprescribers/patients/dispensers not associated with the host device 100,and/or the like. In some embodiments, the host device 100 can beoperable to combine, compile, interlink, and/or otherwise manipulate thestored adverse event reports. In some embodiments, the results of suchoperations can be searchable as described above. In some embodiments,these operations can be performed by an adverse event reporting module(not shown) of the processor 110.

In some embodiments, the patient module 126 is further operable toremind the prescriber 112 and/or the patient 114 to re-enroll thepatient when the patient's enrollment period is about expire. Theprescriber 112 can then communicate with the patient 114, complete a newpatient enrollment form, and re-enroll the patient prior to expiration.As noted earlier for reminders for confirmation forms, reminders can beissued automatically (e.g., by the host device 100), or manually (e.g.,by a telephone operator associated with the host device 100). In someembodiments, the reminders are communicated via any suitable meansspecified by the prescriber 112 at the time of creating the prescriberprofile, such as via email, text message, an automated phone call, anautomated facsimile, a notification via a cloud-based application on theprescriber's smart phone, and/or the like. In some embodiments, theperiodicity of the reminders and/or the determination of whether toissue a reminder or not can be based on one or more of the following: anelapsed duration of enrollment of the patient, a remaining duration ofenrollment of the patient, the specific quantity of the therapeuticagent received by the patient till date (e.g., after the patientreceives his last refill), the therapeutic agent, one or moreindications associated with the therapeutic agent, and/or the like.

In some embodiments, the dispenser module 128 is operable to enroll thedispenser 116 with the host device 100 for one or more of thetherapeutic agents. In some embodiments, the dispenser 116 operates inan out-patient setting and/or dispenses directly to patients, such as aretail pharmacy. In some embodiments, the dispenser 116 operates in anin-patient setting, such as a hospital, a care facility, a mental healthfacility, a prison, and/or the like.

In some embodiments, the dispenser module 128 is operable to directlyreceive a request from the dispenser 116 to be enrolled via any suitablemeans, such as, for example, via a web interface of the dispenser module128, or via a phone call. In other embodiments, the dispenser module 126receives a request to enroll the dispenser 116 indirectly. For example,in some embodiments, the dispenser 116 provides an enrollment requestvia a mail-in form, a facsimile form, or via a telephone call. In suchembodiments, the enrollment request can be entered into the host device100 via the business module 122 (e.g., by a user interacting directlywith the host device), and subsequently (i.e., indirectly) be receivedby the dispenser module 128. In this manner, a dispenser can choose toenroll on-demand such as, for example, when the patient 114 presents aprescription for the therapeutic agent(s) to the dispenser 116.

In some embodiments, the enrollment request includes dispenserenrollment information. In some embodiments, the dispenser enrollmentinformation is received as part of an enrollment form reviewed andcompleted by the dispenser 116. In some embodiments, an incompletedispenser enrollment form is provided to the dispenser 116 in responseto the enrollment request, and the dispenser enrollmentinformation/completed dispenser enrollment form is received in responseto the dispenser (e.g., pharmacist) completing the provided dispenserenrollment form. In some embodiments, the enrollment request is specificfor one or more therapeutic agents and/or one or more indications, andall subsequent enrollment activity is directed towards enrolling thedispenser 116 with the host device 100 for the specific therapeuticagent(s) and/or indication(s).

Explained hereon with respect to one specific therapeutic agent forsimplicity, in some embodiments, in response to an enrollment requestfor a therapeutic agent, the dispenser module is operable to provideeducational information and certification information to the dispenser116, such as via a web interface, email, and/or the like. In otherembodiments, a user of the device 100 is prompted (via the businessmodule 122) to provide printed education information and certificationinformation to the dispenser 116, such as, for example, via postal mailor via facsimile.

In some embodiments, the educational information includes prescriptioninformation for the therapeutic agent, dispenser compliance requirementsfor enrollment, one or more indications associated with the therapeuticagent, one or more side effects associated with the therapeutic agent,adverse event reporting information for the therapeutic agent (whetherassociated with the one or more indications or otherwise), a listing ofadditional educational resources, and/or the like. In some embodiments,the educational information is in the form of a letter. In someembodiments, if the enrollment request specifies two or more therapeuticagents, the educational information can encompass the specifiedtherapeutic agents.

The certification information can include access information for adispenser certification test related to the educational information. Insome embodiments, the access information includes a unique link and/oridentifier for accessing a web-based dispenser certification test thatis conducted by the dispenser module 128. In other embodiments, theaccess information includes a telephone number where a representative ofthe dispenser 114, such as a pharmacist employed by the dispenser, cancall and complete a phone-based automated test. In some embodiments, athird party can administer the dispenser certification test, eitherdirectly via the host device 100 or indirectly (not shown) from a serverand/or host device associated with the third-party. In otherembodiments, the third-party can manually administer the test (e.g., ata testing center, at the prescriber's office, etc.). In someembodiments, the access information is a fillable request (e.g., aprepaid postcard) for a paper copy of the certification test to bemailed to the dispenser 114. In some embodiments, the certificationinformation can include the dispenser certification test.

The dispenser certification test can includes questions in any suitableformat (e.g., multiple choice questions, short answers, and/or the like)that test the representative's ability to understand the educationalinformation. In some embodiments, the dispenser module 128 is operableto wholly analyze the performance of the dispenser's representative onthe dispenser certification test (e.g., responses to multiple choicequestions, via automated textual analysis, and/or the like). In otherembodiments, the dispenser module 128 analyzes a portion of thecertification test, and receives an analysis of a remainder portion ofthe certification test from another entity (e.g., an external testingentity, a user of the device 100, and/or the like). In yet anotherembodiment, the dispenser module 128 communicates with another entitythat wholly analyzes the certification test.

In some embodiments, analysis of the certification test yields anidentifier of the performance of the dispenser's representative. In someembodiments, the identifier is a sliding scale (e.g., 43% correct,56/100 correct, and/or the like) or a discrete scale (e.g., 30-40%correct, 50-60 correct, and/or the like) measure of the performance ofthe dispenser's representative. In some embodiments, the identifier is abinary identifier of the performance of the dispenser's representativesuch as, for example, whether the dispenser's representative achieved athreshold score (“pass”) or not (“fail”). In some embodiments, thecertification test includes several sections, and the identifier can bea combination of identifiers for each section, or a single identifieracross all sections.

In some embodiments, the dispenser module 128 is operable to enroll thedispenser 114 in the host device 100 if the performance of thedispenser's representative meets a performance criterion for thecertification test. The performance criterion for the certificationtest, or for a section thereof, can be one or more of the following: athreshold measure (e.g., at least 60%), a binary measure (e.g., mustachieve a “pass” score, as discussed above), and/or the like. In someembodiments, the duration of enrollment of the dispenser 114 is based onthe performance of the dispenser's representative (e.g., a higher scoreresults in a greater duration of enrollment than a lower score, and viceversa). For example, if the dispenser's score is above a first thresholdbut below a second threshold, the dispenser can be authorized todispense the therapeutic agent for a first time period. If, however, thedispenser's score is above both the first threshold and the secondthreshold, the dispenser can be authorized to dispense the therapeuticagent for a second time period greater than the first time period.

In some embodiments, enrolling the dispenser 116 includes providing thedispenser enrollment form to the dispenser 116 via the dispenser module128 and/or directly or indirectly receiving the completed enrollmentform from the dispenser. The dispenser enrollment form can include anindication whether the dispenser is in an in-patient and/or outpatientsetting, the dispenser facility name, the dispenser facility type (e.g.,for in-patient pharmacies), a registration identifier for the dispenser,contact information, credentials, specialty, contact information for adesignated representative of the dispenser, consent to a contractualagreement provided for in the dispenser enrollment form, and/or thelike. In some embodiments, the contact information is included; in thismanner, enrolling the dispensing facility to receive and dispense thetherapeutic agent(s) effectively includes enrolling at least onepharmacist associated with the dispensing facility.

The dispenser module 128 is further operable to, in response toreceiving the dispenser enrollment form, generate a certificationidentifier for the dispenser 112. The dispenser module 128 is furtheroperable to generate a dispenser profile for the dispenser 116, and tostore the prescriber profile in the memory 160 and/or the database 170(e.g., via the database module 136). The dispenser profile can include,but is not limited to, the dispenser enrollment information, thecertification identifier, the therapeutic agent(s) for which thedispenser 116 is enrolled, a duration of enrollment of the dispenser 116for each therapeutic agent, the indication(s) for which the dispenser116 is enrolled, and/or the like.

Although described herein with respect to embodiments where thedispenser 116 requests to be enrolled, in other embodiments, thedispenser module 128 is operable to invite the dispenser to enroll byproviding to the dispenser and/or a pharmacist associated therewith,without input from the dispenser and/or the pharmacist, the educationalinformation. The prescriber 112 can then opt to be enrolled in a mannersimilar to as described above.

The authorization module 130 can be configured to receive anauthorization request from the dispenser, and generate codes to allowthe dispenser to provide the therapeutic agent to the patient afterverifying certain dispensing requirements, as described in furtherdetail herein. In some embodiments the authorization module 130 can beconfigured to automatically generate codes to allow the dispenser toprovide the therapeutic agent to the patient after verifying the certaindispensing requirements. In some embodiments, the authorization requestis received from the prescriber and/or from the patient. Furtheroperation of the authorization module 130 can, for example, be describedwith respect to the following non-limiting scenario. A patient 114visits a prescriber 112, where the prescriber 112 deems that the patient114 should be prescribed a therapeutic agent managed by the host device100. The prescriber 112 enrolls or is already enrolled with the hostdevice 100 for the therapeutic agent as described above, and proceeds toproperly advise the patient 114, conduct required diagnostic test(s),complete and submit the patient enrollment form to the host device 100,and issue a prescription for the therapeutic agent to the patient 114.The prescriber 112 and/or the patient 114 then presents the prescriptionto the dispenser 116, where the dispenser enrolls or is already enrolledwith the host device 100. In some embodiments, the prescription includesprescriber information (including a certification identifier of theprescriber), dispensing information, refill information and/or the like.The dispenser 116 requests authorization, from the host device 100, todispense the therapeutic agent to the patient. In some embodiments, thedispenser 116 requests authorization over a web interface of thedispenser module 128 and/or the authorization module 130.

The authorization module 130 is then operable to receive theauthorization request from the dispenser. In some embodiments, theauthorization module 130 is further operable to determine if the patient114 can receive the therapeutic agent based on whether the prescriber112 is currently enrolled and/or authorized to prescribe the therapeuticagent. For example, in such embodiments, the authorization module 130can access the prescriber profile of the prescriber 112 in the database170 via the database module 136. If no such prescriber profile exists,or if the prescriber profile does not include the prescribed therapeuticagent, or if a predetermined period of time has elapsed since theprescriber's last certification test date, and so on, the authorizationmodule 130 determine that the prescriber 112 is not authorized. In someembodiments, the prescriber profile can include a flag indicating thestatus of the prescriber 112 as authorized/unauthorized, asactive/inactive, and/or the like, and the authorization module 130 candetermine whether the prescriber is authorized based on the flag.

In some embodiments, the authorization module 130 is further operable todetermine if the patient 114 can receive the therapeutic agent based onwhether the dispenser 116 is currently enrolled and/or authorized todispense the therapeutic agent, such as by, for example, accessing adispenser profile of the dispenser in the database 170 via the databasemodule 136.

In some embodiments, the authorization module 130 is further operable todetermine if the patient 114 is authorized to receive the therapeuticagent. In some embodiments, determining whether the patient isauthorized includes determining whether the patient 114 is activelyenrolled with the host device 100. In some embodiments, determiningwhether the patient is authorized includes determining whether theprescriber 112 has provided a confirmation of a satisfactory diagnostictest result for the patient 114 as part of the patient enrollment form.In some instances, such as when the patient requests a refill of theprescription from the dispenser 116, determining whether the patient isauthorized includes determining whether the prescriber 112 has provideda subsequent confirmation of a satisfactory diagnostic test result forthe patient 114. In some embodiments, determining whether the patient isauthorized includes determining whether the satisfactory diagnostic testresult was received within a first predetermined time period such as,for example, within the past 30 days, or within 30 days from the lastdate of dispensing the therapeutic agent to the patient 114. In thismanner, if a patient tests satisfactorily in a timely manner, he canreceive the prescribed quantity.

In some embodiments, if the satisfactory diagnostic test result is notreceived within the first predetermined time period, determining whetherthe patient is authorized includes determining whether the authorizationrequest was received within a second predetermined time period such as,for example, within 7 days from the end of the first predeterminedperiod. In this manner, if the patient 114 has been unable to undergodiagnostic testing, and/or the prescriber 112 has been unable to provideconfirmation of satisfactory diagnostic test results in a timely manner,the patient 114 can still receive a limited quantity of the therapeuticagent to avoid discontinuation of treatment.

In some embodiments, if the satisfactory diagnostic test result is notreceived within the first predetermined time period, the determiningwhether the patient is authorized includes determining whether adispensing request is received from the prescriber 112 and associatedwith the patient profile of the patient 114. In this manner, aprescriber 112 can specify that the patient can receive a limitedquantity of the therapeutic agent to avoid discontinuation of treatment,pending diagnostic test results. In some embodiments, the dispensingrequest authorizes the patient 114 to receive the therapeutic agentirrespective of how much time has elapsed since the last time thepatient received the therapeutic agent. In other embodiments, thedispensing request authorizes the patient 114 to receive the therapeuticagent if the dispensing request is received in a specific timeframe suchas, for example, after expiration of the first predetermined time periodand/or before expiration of the second predetermined time period.

In some embodiments, the authorization module 130 is operable togenerate and/or update one or more codes (in some embodiments, alsoreferred to as ‘authorization codes’). In some embodiments, the one ormore codes are generated upon creation of the patient profile, and canbe associated with the patient profile. For example, if the patient isto be enrolled for a year, and will receive an initial standard quantityof the therapeutic agent at enrollment, plus eleven refills, in someembodiments, twelve codes can be associated with the patient profile atthe time of generation of the patient profile. Each code can be set to aprohibition and/or warning code (described in further detail herein) bydefault. In other embodiments, when a satisfactory diagnostic testresult is received at the time of generation of the patient profile,twelve codes can be associated with the patient profile at the time ofgeneration of the patient profile, with the first code being a standardauthorization code (described in further detail herein), and theremaining codes being prohibition/warning codes. Each of the codes canthen be modified based on one or more subsequent events such as, but notlimited to, receipt of a diagnostic test result, receipt of an adverseevent report, receipt of a dispensing request, transmission of the codeto a dispenser, and/or the like. In other embodiments, the codes can besuccessively generated and associated with the patient profile, andupdated based on the one or more subsequent events.

Describing the generation and updating of the codes in more detail, insome embodiments, the one or more codes are generated and/or updated inresponse to receipt of satisfactory diagnostic test results, or inresponse to confirmation of satisfactory diagnostic test results by aprescriber. In some embodiments, the one or more codes are generatedand/or updated in response to receipt of an adverse event report. Insome embodiments, the one or more codes are generated and/or updated inresponse to receipt of a dispensing request from the prescriber. In someembodiments, the one or more codes are generated and/or updated inresponse to the authorization request from the dispenser. In someembodiments, the one or more codes are updated upon transmission of theone or more codes to a dispenser. In some embodiments, the one or morecodes are updated in response to confirmation of dispensing thetherapeutic agent to the patient.

In embodiments where the satisfactory diagnostic test results werereceived within a first predetermined time period, the authorizationmodule 130 can be operable to transmit a standard authorization code tothe dispenser 116. In some embodiments, the standard authorization code(e.g., a first authorization code) is communicative of a permission forthe dispenser 116 to dispense a first quantity of the therapeutic agentto the patient 114. In some embodiments, the first quantity is aprescribed and/or standard quantity.

In instances where the satisfactory diagnostic test result is notreceived within the first predetermined time period the authorizationrequest was received within a second predetermined time period, theauthorization module 130 can be operable to generate and transmit atemporary authorization code to the dispenser 116. In some embodiments,the temporary authorization code (e.g., a second authorization code) iscommunicative of a permission for the dispenser 116 to dispense a secondquantity of the therapeutic agent to the patient 114. In someembodiments, the second quantity is different from the first quantity.In some embodiments, the second quantity is less than the firstquantity.

In instances where the confirmation of satisfactory diagnostic testresults is not received within the first predetermined time period andthe dispensing request from the prescriber 112 has not been received,the authorization module 130 can be operable to generate and transmit aprohibition code to the dispenser 116. In some embodiments, theprohibition code (in some embodiments and/or instances, also referred toas a ‘third authorization code’) is communicative of forbidding and/orprohibiting the dispenser 116 from dispensing the therapeutic agent tothe patient 114.

In some embodiments, the standard authorization, temporaryauthorization, and prohibition codes are different from each other. Thecodes can be of any suitable type as known in the art, and includealphanumeric characters, symbolic characters, images/graphic elements,and/or the like. In some embodiments, the codes are generated based onand/or able to identify prescriber enrollment information, patientenrollment information, dispenser enrollment information, thetherapeutic agent, time and/or date information (associated with thediagnostic test, with the authorization request, with generation and/ortransmission of the code(s), and/or the like), a random number, and/orthe like.

In some embodiments, the authorization module 130 is operable toassociate the generated/transmitted code with the patient profile,and/or update the patient profile with the generated/transmitted code.In some embodiments, the authorization module 130 receives confirmationof the therapeutic agent being dispensed to the patient 114, and isoperable to associate the dispensing event with the patient profile(e.g., via the patient module 126). The confirmation can includedispensing information, including a time/date of dispensing, a lotnumber of the therapeutic agent being dispensed, and/or the like. Insome embodiments, the authorization module 130 is operable to associatethe dispensing event with the corresponding code authorizing thedispensing event. For example, in some embodiments, the authorizationmodule 130 associates a lot number of the dispensed therapeutic agentwith a standard authorization code, or updates the standardauthorization code with the lot number (e.g., by appending the lotnumber to the end of the standard authorization code). In anotherexample, the authorization module 130 associates a lot number of thedispensed therapeutic agent with a temporary authorization code, orupdates the temporary authorization code with the lot number. In someembodiments, the lot number is indicative of the second quantity of thedrug. For example, in some embodiments, aspects of this disclosure areoperable in the scenario where the dispenser is provided the therapeuticagent for dispensing in two quantities: a first quantity and a secondquantity. In this manner, dispensing the first quantity or the secondquantity of the therapeutic agent to the patient can be tracked via thecode associated with the dispensing event, via the lot number associatedwith the dispensing event, or both.

Returning to describe the business module 122, as noted about and in thedescriptions of the various modules, the business module 122 canfacilitate entry of information at the host device 100 by a user and/ora compute device that interacts with the prescriber 112, the patient114, and/or the dispenser 116. For example, the user can receiveprescriber enrollment forms via postal mail and then enroll theprescriber 112 by entering the information from the prescriberenrollment forms into host device 100, or at a compute device of theuser and associated with the host device. For another example, the usercan be a call center employee that communicates with the prescriber overthe telephone, and enters the prescriber enrollment information into thehost device 100 to define the prescriber profile. In this manner,aspects of this disclosure encompass any combination of different modesof interaction (electronic, verbal, telecommunication, postal, etc.)between the host device 100, the prescriber 112, the patient 114, and/orthe dispenser 116.

In some embodiments, the business module 122 is further operable toperiodically report adverse event reports stored in the memory 160and/or the database 170 to a third party, such as a regulatory body. Insome embodiments, the business module 122 is further operable toperiodically synchronize adverse event reports for the one or moretherapeutic agents and/or indications managed by the host device 100with external adverse event databases.

Explained with reference to FIG. 1, FIG. 2 illustrates a method 200 ofenrolling a prescriber, such as the prescriber 112, at the host device100 for a therapeutic agent associated with at least one indication,according to an embodiment. In some embodiments, the therapeutic agentis tolvaptan. In some embodiments, the at least one indication includeshyponatremia. In some embodiments, the at least one indication includesautosomal dominant polycystic kidney disease (ADPKD). In someembodiments, the therapeutic agent is associated with multipleindications.

At 210, a request is received to enroll the prescriber 112 with the RMShost device 100. In response, at 220, educational information/materialis provided to the prescriber 112. Further, at 230, certificationinformation is provided to the prescriber 112 that includes, access to acertification test that is related to the educational material. Theprescriber 112 takes the certification test, such as at a compute deviceof the prescriber, and at 240, the host device 100 receives anidentifier of a performance of the prescriber on the test. At 250, theprescriber is enrolled, at the host device, in the RMS if theperformance of the prescriber meets a performance criterion for thetest. In some embodiments, enrolling the prescriber 112 includesauthorizing the prescriber to prescribe the therapeutic agent.

In some embodiments, enrolling includes enrolling the prescriber 112 fora predetermined time period, such as a prescriber enrollment period. Insome embodiments, the method 200 further includes providing, after theenrolling and to the prescriber, prior to lapse of the predeterminedtime period, reenrollment information associated with the RMS and withthe therapeutic agent. In some embodiments, the method 200 also includesreceiving consent from the prescriber in response to the reenrollmentinformation, and reenrolling, at the host device 100, the prescriber inthe RMS in response to receiving the consent.

Explained with reference to FIG. 1, FIG. 3 illustrates a method 300 ofenrolling a pharmacy, such as the dispenser 116, at the host device 100for a therapeutic agent associated with at least one indication,according to an embodiment. In some embodiments, the therapeutic agentis tolvaptan. In some embodiments, the at least one indication includeshyponatremia. In some embodiments, the at least one indication includesautosomal dominant polycystic kidney disease (ADPKD). In someembodiments, the therapeutic agent is associated with multipleindications.

At 310, a request is received at the RMS host device 100 to enroll thepharmacy in the RMS. At 320, educational information/material isprovided to a pharmacist associated with the pharmacy. Further, at 330,the pharmacist/pharmacy is provided access to a certification testrelated to the educational material. The pharmacist takes the test, andat 340, an identifier of a performance of the pharmacist on the test isreceived by the host device 100. At 350, the pharmacy is enrolled in theRMS if the performance of the pharmacist meets a performance criterionfor the certification test. In some embodiments, enrolling the pharmacyincludes authorizing the pharmacy to dispense the therapeutic agent.

In some embodiments, enrolling the pharmacy includes enrolling thepharmacy for a predetermined time period, such as a dispenser enrollmentperiod. In some embodiments, the method 300 further includes providing,after the enrolling, and to the pharmacist prior to lapse of thepredetermined time period, reenrollment information associated with theRMS and with the therapeutic agent. The method also includes receivingconsent from the pharmacist in response to the reenrollment informationand reenrolling the pharmacist in the RMS in response to receiving theconsent.

Explained with reference to FIG. 1, FIG. 4 illustrates a method 400 ofauthorizing a pharmacy (e.g., the dispenser 116) to dispense atherapeutic agent associated with at least one indication to a patient,such as the patient 114, according to an embodiment. In someembodiments, the therapeutic agent is tolvaptan. In some embodiments,the at least one indication includes hyponatremia. In some embodiments,the at least one indication includes autosomal dominant polycystickidney disease (ADPKD). In some embodiments, the therapeutic agent isassociated with multiple indications.

At 410, a confirmation of a diagnostic test of a patient enrolled in theRMS is received at the host device 100 by the prescriber 112, where theprescriber is already enrolled with the RMS. At 420, based on thereceipt of the confirmation from the prescriber 112, an authorizationcode is generated that indicates whether the pharmacy enrolled in theRMS is authorized to dispense the therapeutic agent to the patient 114.At 430, a request is received, from the pharmacy, to dispense thetherapeutic agent to the patient 114, and at 440, the authorization codeis provided to the pharmacy.

In some embodiments, the confirmation includes an identifier of a dateon which the diagnostic test was performed on the patient, and the codeis generated if the request is received within a predetermined timeperiod from the date. In some embodiments, the confirmation includes anidentifier of a date on which the diagnostic test was performed on thepatient, and the code is valid for a predetermined time period from thedate.

In some embodiments, the method 400 further includes transmitting, fromthe host device 100 to the prescriber 114, a request for theconfirmation of the diagnostic test. The confirmation can be received inresponse to the request for the confirmation. In some embodiments, themethod 400 further includes verifying that at least one of the pharmacyor a pharmacist associated with the pharmacy is enrolled in the RMSprior to providing the authorization code. In some embodiments, themethod 400 further includes verifying an enrollment status of theprescriber prior generating the code.

In some embodiments, the confirmation includes confirmation of asuccessful diagnostic test, and the authorization code authorizes thepharmacy to dispense the therapeutic agent to the patient. In someembodiments, the confirmation includes confirmation of an unsuccessfuldiagnostic test and/or an adverse event associated with the patientusing the therapeutic agent, and the authorization code prohibits thepharmacy from dispensing the therapeutic agent to the patient. In someembodiments, the adverse event is associated with one or more sideeffects associated with the at least one indication. In otherembodiments, the adverse event is associated with one or more sideeffects unrelated to the at least one indication.

Explained with reference to FIG. 1, FIG. 5 illustrates another method500 of authorizing a pharmacy (e.g., the dispenser 116) to dispense atherapeutic agent associated with at least one indication to a patient,such as the patient 114, according to an embodiment. In someembodiments, the therapeutic agent is tolvaptan. In some embodiments,the at least one indication includes hyponatremia. In some embodiments,the at least one indication includes autosomal dominant polycystickidney disease (ADPKD). In some embodiments, the therapeutic agent isassociated with multiple indications.

At 510, a request is received at the RMS host device 100 from thepharmacy already enrolled with the host device, to dispense a firstquantity (e.g., a prescribed and/or standard quantity) of thetherapeutic agent to a patient already enrolled with the host device(e.g., by the dispenser module 128).

At 520, the host device 100 determines if a confirmation of a successfuldiagnostic test of the patient has been received from a prescriber(e.g., the prescriber 112) within a first predetermined time period suchas can be received by the prescriber module 124, for example). If theconfirmation is received, a first authorization code is generated at530, and the generated first authorization code is transmitted to thepharmacy at 570 a. In some embodiments, the first authorization codepermits the pharmacy to dispense a first quantity of therapeutic agentto the patient.

If the confirmation is not received (as determined at step 520), then at540A, the host device 100 determines if the request from the pharmacy isreceived within a second predetermined time period. If this is the case,then a second authorization code is generated at 550 (e.g., by theauthorization module 130), and the generated second authorization codeis transmitted to the pharmacy at 570 b.

If the request from the pharmacy is not received within a secondpredetermined time period (as determined at step 540A), then at 540B,the host device 100 determines if a request is received from theprescriber (e.g., a dispense request, as described earlier) to dispensea second quantity of the therapeutic agent to the patient. If this isthe case, then the second authorization code is generated at 550 (e.g.,by the authorization module 130), and the generated second authorizationcode is transmitted to the pharmacy at 570 c. If this is not the case,then a third authorization code is generated at 560, and the generatedthird authorization code is transmitted to the pharmacy at 580. In someembodiments, the second authorization code permits the pharmacy todispense a second quantity of the therapeutic agent to the patientwithout the confirmation of a successful diagnostic test. In someembodiments, the second quantity is less than the first quantity. Insome embodiments, the third authorization code prohibits the pharmacyfrom dispensing the therapeutic agent to the patient.

It is understood that while FIG. 5 illustrates that step 540A isperformed before step 540B, in other embodiments, steps 540A and 540Bcan be performed substantially in parallel, and in yet otherembodiments, step 540B can be performed before 540A. Irrespective of theorder in which steps 540A and 540B are performed, it is furtherunderstood that (as is also the case in the illustrated embodiment ofFIG. 5) the second authorization code is generated if either step 540Aor step 540B is found to be true, and that the third authorization codeis generated if both step 540A and step 540B are found to be false. Inyet other embodiments, one of step 540A or step 540B is performed, thesecond authorization code is generated if the performed step is found tobe true, and the third authorization code is generated if the performedstep is found to be false.

In yet other embodiments, steps 540A and 540B are performed sequentiallyor substantially in parallel, the second authorization code is generatedif both steps 540A, 540B are found to be true, and the thirdauthorization code is generated if either of the steps 540A, 540B arefound to be false. In this manner, the patient receives the secondquantity of the therapeutic agent if the prescriber sends in thedispensing request and the pharmacy makes an authorization requestwithin the second predetermined time period, and not otherwise.

Explained with reference to FIG. 1, FIG. 6 illustrates a method 600 ofwhether a patient, such as the patient 114, is authorized to receive atherapeutic agent for a first indication of multiple indicationsassociated with the therapeutic agent, according to an embodiment. Insome embodiments, the therapeutic agent is tolvaptan. In someembodiments, the indications include hyponatremia. In some embodiments,the indications includes autosomal dominant polycystic kidney disease(ADPKD).

At 610, a request is received, at a host device of a RMS (e.g., by thepatient module 126 and/or the prescriber module 124) for a therapeuticagent associated with a multiple indications, from a prescriber, arequest to enroll a patient in the RMS. In some embodiments, the requestincludes a specification of an indication from the multiple indications,such as a first indication or a second indication, and a confirmation ofa diagnostic test conducted on a patient. The diagnostic test can beassociated with the therapeutic agent and with the specified indication.At 620, the patient is enrolled in the RMS at the host device and inresponse to the request (e.g., by the patient module 126). In someembodiments, enrolling the patient includes identifying a predeterminedenrollment period based on the indication. The predetermined enrollmentperiod can have a first duration when the indication is a firstindication from the multiple indications. The predetermined enrollmentperiod can have a second duration different from the first duration whenthe indication is a second indication from the multiple indications.Hence, in some embodiments, at least two indications, such as the firstindication and the second indication, are associated with differentdurations of enrollment. In other embodiments, each indication can beassociated with a different duration of enrollment. At 630, a firstauthorization code is generated based on the predetermined enrollmentperiod (e.g., by the authorization module 130). The first authorizationcode can indicate whether the patient is authorized to receive thetherapeutic agent.

In some embodiments, the method 600 further includes receiving a requestfrom a pharmacy to dispense a refill of the therapeutic agent to thepatient. The method 600 can additionally include generating a newauthorization code indicating whether the patient is authorized toreceive a refill of the therapeutic agent. In some embodiments,generating the new authorization code for the first indication isdifferent from generating the new authorization code for the secondindication. Similarly stated, a different approach, algorithm, process,and/or the like can be employed depending on the indication for whichthe patient is receiving the therapeutic agent. In some embodiments, thesame approach, algorithm, process, and/or the like can be used forgenerating the new authorization code for two or more indications.

In some embodiments, the confirmation of the diagnostic test is a firstconfirmation. In some embodiments, when the indication is the firstindication, the method 600 can include generating the new authorizationcode in response to receiving, at the host device and from theprescriber, a confirmation of a second diagnostic test within thepredetermined enrollment period. For example, if the patient is enrolledfor a year and the patient is required to undergo testing every month toobtain a monthly refill of the therapeutic agent, the first duration canbe about a month, or less than a month. The second diagnostic test canbe related to, for example, a refill request or a reenrollment request.In some embodiments, when the indication is the second indication, themethod 600 can include generating the new authorization code in responseto receiving a request within the predetermined enrollment period andwithout receiving the confirmation of the second diagnostic test. Forexample, if the patient is enrolled for a month, then the secondduration can be a month and the second confirmation is properly receivedanytime within the second duration without requiring confirmation of asubsequent diagnostic test.

In some embodiments, the method 600 further includes providing, afterthe enrolling and to the prescriber, prior to lapse of the firstpredetermined enrollment period, patient reenrollment informationassociated with: (1) the RMS, (2) the therapeutic agent, and (3) thefirst indication. In some embodiments, the method 600 additionallyincludes receiving consent from the prescriber and the patient inresponse to the patient reenrollment information, and reenrolling, atthe host device, the patient in the RMS in response to receiving theconsent.

In some embodiments, the method 600 further includes receiving, at thehost device, for the therapeutic agent, from a prescriber, a request toenroll the prescriber in the RMS. The method 600 can additionallyinclude providing, to the prescriber, educational material associatedwith the RMS, the therapeutic agent and/or the indication. The method600 can also include providing, to the prescriber, access to a testrelating to the educational material, and receiving, at the host device,an identifier of a performance of the prescriber on the test. The method600 can further include enrolling, at the host device, the prescriber inthe RMS if the performance of the prescriber meets a performancecriterion for the test.

In some embodiments, the method 600 further includes receiving, at thehost device, for the therapeutic agent, from a pharmacy, a request toenroll the pharmacy in the RMS. The method 600 can additionally includeproviding, to a pharmacist associated with the pharmacy, educationalmaterial associated with the RMS, the therapeutic agent and/or theindication. The method 600 can further include providing, to thepharmacist, access to a test relating to the educational material, andreceiving, at the host device, an identifier of a performance of thepharmacist on the test. The method 600 can also include enrolling, atthe host device, the pharmacy in the RMS if the performance of thepharmacist meets a performance criterion for the test.

FIGS. 7A-7E are illustrations of interactions between the variousentities of FIG. 1 in the scenario in which the RMS device 100 is a REMShost that is compliant with the FDA's REMS requirement, according to anembodiment. FIGS. 7A-7E illustrate a RMS Host 700 (similar to the hostdevice 100), a prescriber 712 (similar to the prescriber 112), a patient714 (similar to the patient 114), and a pharmacy 716 (similar to thedispenser 116).

FIG. 7A is an illustration of prescriber enrollment and patientenrollment, according to an embodiment. At 720, the prescriber 712receives a package containing educational information and certificationinformation, inviting the prescriber 712 to enroll in a REMS program atthe REMS host 700. At 722, the prescriber 712 uses the packageinformation to contact the REMS Host 700 to obtain the training programand to subsequently take the prescriber certification test, which areprovided/administered by the REMS host 700 at 724 (or a third-party).Assuming the prescriber 712 meets performance criterion for thecertification test, at 726, the prescriber completes and submits aprescriber enrollment form to the REMS Host 700 via any suitable meanssuch as email, online via a web interface, via fax, and/or the like. TheREMS Host 700, at 728, confirms receipt of the prescriber enrollmentform and registers the prescriber 712 in the REMS program (e.g.,generates and saves a prescriber profile in a database). The REMS Host700 also sends the prescriber 712 a password for future access to theREMS program/web site.

After enrolling, the prescriber 712 can prescribe the therapeutic agentpursuant to conditions agreed upon during prescriber enrollment.Accordingly, when the prescriber 712 determines, during counseling thepatient 714, that the patient should receive the therapeutic agent ordrug, the prescriber orders a liver function test (LFT) for the patientat 730. The patient 714 undergoes the test at 732, and at 734, theprescriber 712 determines whether the LFT satisfies specific baselineparameters for markers such as total bilirubin, alanineaminotransferase, aspartate aminotransferase and/or the like. If thebaseline parameters are not satisfied, no further action is taken. Ifthe baseline parameters are satisfied, the prescriber 712 can counselthe patient 714 at 738, including explaining the risks of the drug,educate the patient about the drug and the need for periodic LFT, andsubmitting a patient prescriber agreement form (similar to a patientenrollment form) to the patient 714 at 736. The patient 714 in turn,receives the counseling/education, and signs the patient-prescriberagreement form at 736. At 740, the prescriber 712 submits the signedpatient-prescriber agreement to the REMS Host 700, which in turnregisters the patient 714 in the REMS program. The prescriber 712 cansubsequently order monthly LFTs for the patient 714 at 744, at whichpoint the prescriber can provide the patient the LFT order forms for hisconvenience/records, and a helpful starter kit for the drug, includingdirections for use, the importance of monthly testing, and/or the like.

FIG. 7B is an illustration of pharmacy enrollment, according to anembodiment. At 746, the pharmacy 716 can designate (at 746) arepresentative to undergo the training/certification program forenrollment in the REMS program hosted by the REMS Host 700. At 748, therepresentative reviews enrollment information in a received package. At750, the representative accesses the training program on the REMS Host700 and takes the certification test. At 752, the REMS host 700 providesthe training program and administers the prescriber certification test.If the representative's performance meets a performance criterion forthe prescriber certification test, then at 754, the representative oranother pharmacy member submits the pharmacy enrollment form (similar toa prescriber enrollment form) to the REMS Host 700, which in turn (amongother things) registers the pharmacy 716 with the REMS program.

FIG. 7C is an illustration of dispensing a first prescription for thepatient 714, according to an embodiment. At 758, the prescriber 712sends a prescription for the therapeutic agent/drug to the pharmacy 716,either as part of the patient-prescriber agreement form or separately.The prescriber 712 can also (see step 760) send other patientinformation, such as insurance information, to the REMS Host 700. TheREMS Host 700 can register the received information by, for example,associating the information with a patient profile of the patient 714.The pharmacy confirms, prior to dispensing the drug based on theprescriber, whether the prescriber is enrolled in the REMS program (seestep 766) and whether the patient is enrolled in the REMS program (seestep 768). The pharmacy 716 can then contact the patient 712 to confirmdelivery option (e.g., a mailing address of the patient) at 772. Thepatient confirms delivery information at 772, in response to which thepharmacy 716 delivers the drug to the patient at 774, who receives it at776. The pharmacy 716 also transmits the delivery information to theREMS program at 778, and the REMS Host registers the delivery at 780 by,for example, associating the delivery with the patient profile of thepatient 714.

FIG. 7D is an illustration of dispensing a subsequent prescription(e.g., a refill) for the patient, according to an embodiment. Assumingthe patient receives a refill every 28 days during enrollment, at 782,the REMS Host 700, not having received confirmation of a LFT, sends areminder to the patient 714 for the LFT at 782 (the patient receives thereminder at 784), and a reminder to the prescriber 712 for theconfirmation of the LFT at 786 (the prescriber receives the reminder at788), both reminders sent and received 20 days before the next refilldate. At 790, approximately 10 days before the next refill date, theREMS Host 700 determined whether a test confirmation form (here, ahepatic monitoring confirmation form, or HMCF) is received. If not, aphone call reminder is placed to the prescriber 712 at 792, and isreceived by the prescriber at 794.

At some point, the patient 714 completes the LFT at 796, and the LFTresults are received (step 798) and reviewed (step 800) by theprescriber 712. If the prescriber 712 deems the LFT results to beunsuitable for continued prescription of the therapeutic agent, theprescriber reports the unfavorable results at D (described in moredetail in FIG. 7E). If the prescriber 712 deems he LFT results to besuitable, the prescriber can order a refill for the patient 714, as wellas send the HMCF to the REMS Host 700. The pharmacy 716 receives therefill prescription at 806, and the REMS Host 700 receives the HMCF at808, and can update the patient status (e.g., the patient profile) basedon the HMCF.

The pharmacy 716 confirms prescriber enrollment (step 810) and patientenrollment (step 812). The pharmacy 716 also ensures, by contacting theREMS Host 700, that a HMCF was received, at 814. Steps 810, 812, 814 cangenerally encompass an authorization request from the pharmacy 716 tothe REMS Host 700 prior to dispensing the drug, as discussed earlier,and the response(s) received therefrom. The REMS Host 700 checks at 816to ensure at least one HMCF associated with the patient profile wasreceived within 30 days from the last time the therapeutic agent wasdispensed. If this is not the case, no further action is take by theREMS Host 700 or the pharmacy 716. If the condition at 816 is satisfied,the pharmacy 716 can proceed to dispense the drug in a manner similar todescribed above, include confirming delivery operation at 818 (thepatient 714 confirms at 820) and sending the drug at 822 (the patientreceives the drug at 824). The pharmacy 716 also transmits deliveryinformation to the REMS Host 700 at 826, and the REMS Host registers thedelivery information at 828.

FIG. 7E is an illustration of the prescriber 714 reporting unfavorableLFT reports, according to an embodiment. At 830, the prescriber 814completes a hepatotoxicity reporting form (HRF), such as can be providedto the REMS Host via a web interface, email, fax, and/or the like. At832, the REMS Host 700 receives the HRF and, in this embodiment, sharesthe HRF with, for example, the manufacturer of the drug. At 834, theREMS Host 700 further ensures the patient does not receive additionalquantities of the drug by changing the status of the patient toinactive, thereby effectively ‘un-enrolling’ the patient 714.

Explained with reference to FIG. 1, FIG. 8 illustrates a method 800 ofauthorizing a patient, such as the patient 114, to receive a therapeuticagent associated with multiple indications, if the patient meets certainenrollment criteria. In some embodiments, the patient can be enrollingin RMS for the first time. In other embodiments, the patient can bereenrolling in the RMS and/or obtaining a refill of the therapeuticagent. In some embodiments, the therapeutic agent is tolvaptan. In someembodiments, the indications include hyponatremia. In some embodiments,the indications includes autosomal dominant polycystic kidney disease(ADPKD).

At 810, a request to dispense a quantity of the therapeutic agent to apatient is received from a compute device associated with a pharmacyenrolled in the RMS, such as the dispenser 116. In some embodiments, therequest can include a specification and/or identifier of an indicationfrom the multiple indications. In other embodiments, the request caninclude an identifier associated with the indication and/or patient andthe RMS can identify the indication based on analyzing a profile of thepatient in the RMS and identified by the identifier associated with theindication and/or patient.

At 820A, it is determined (e.g., by the patient module 126) if theindication is a first indication from the multiple indications and ifthe request meets a patient enrollment criterion associated with thefirst indication. If this is found to be the case, a first authorizationcode is generated at 830 (e.g., by the authorization module 130), andthe patient is enrolled (or reenrolled) in the RMS for a first durationat 840. The enrollment criterion can be any suitable requirement(s) thatthe request must/should meet for patient enrollment including, but notlimited to, that the request specify diagnostic test results related tothe therapeutic agent (e.g., to monitor the potential for and/or theactual occurrence of adverse side effects), that the request includerequested patient identification information, that the request identifythe first indication, and/or the like. At 850, the first authorizationcode is provided to the pharmacy, such as by, for example, theauthorization module 130 (e.g., sent to a compute device of the pharmacyvia a network, telephonically, and/or the like).

In some embodiments, the first indication is autosomal dominantpolycystic kidney disease (ADPKD), and the patient enrollment criterionassociated with the first indication includes confirmation of adiagnostic test, and further includes an indication of diagnosis ofADPKD. In some embodiments, the diagnostic test can be a liver functiontest (LFT).

Substantially simultaneously, before, or after step 820A, at 820B, it isdetermined (e.g., by the patient module 126) if the indication is asecond indication from the multiple indications and the request meets apatient enrollment criterion associated with the second indication. Ifthis is found to be the case, a second authorization code is generatedat 860, and the patient is enrolled (or reenrolled) in the RMS for asecond duration at 870. In some embodiments, the second indication ishyponatremia, and the second patient enrollment criterion includes atleast one of: an indication of diagnosis of hyponatremia; a date ofhospitalization of the patient; a date of initiation of treatment withthe therapeutic agent (e.g., in a hospital setting); a name and locationassociated with the site of treatment (e.g., a name and address of anhospital where the patient is being treated); an indication of a dailydose of the treatment with the therapeutic agent; or an indication ofthe patient's serum sodium concentration. At 880, the firstauthorization code or the second authorization code is provided to thepharmacy, such as by, for example, the authorization module 130 (e.g.,sent to a compute device of the pharmacy via a network, telephonically,and/or the like). In some embodiments, if the conditions of step 820Aare satisfied, then step 820B is not executed, and vice versa, i.e., ifstep 820B are satisfied, then step 820A is not executed.

In other embodiments, instead of performing steps 820A and 820B, the RMSidentifies the indication for which the request is associated after step810. If the request is associated with the first indication, the RMSdetermines whether the request meets a first patient enrollmentcriterion, and if so, proceeds to step 830. If the request is associatedwith the second indication, the RMS determines whether the request meetsa second patient enrollment criterion, and if so, proceeds to step 860.In such an embodiment, the RMS identifies the indication prior toanalyzing the enrollment criterion. In such embodiments, the enrollmentcriterion for the identified indication is analyzed, but the enrollmentcriterion for the non-identified indication is not analyzed.

In some embodiments, at step 890, if the request does not meet thepatient enrollment criterion for either indication, the patient is notenrolled (or reenrolled), and the pharmacy is not authorized to dispensethe therapeutic agent to the patient. This can be communicated to thepharmacy and/or patient in any suitable manner including, for example,not responding to the request, generating a code indicative of therequest not meeting the dispensation criterion, and/or the like. In someembodiments, the first indication is autosomal dominant polycystickidney disease (ADPKD) and the second indication is hyponatremia. Inother embodiments, the first indication and/or the second indication canbe any other suitable indications associated with a therapeutic agent.

Explained with reference to FIG. 1, FIG. 9 illustrates a method 900 ofauthorizing a patient, such as the patient 114, to receive a therapeuticagent associated with of the patient's indication, if certaindispensation criteria associated with either the patient's indication,or another indication associated with the therapeutic agent are met. Insome embodiments, the patient can be enrolling in RMS for the firsttime. In other embodiments, the patient can be reenrolling in the RMSand/or obtaining a refill of the therapeutic agent. For example, method900 can be used for a patient already enrolled in the RMS, but needing arefill of the therapeutic agent. In some embodiments, the therapeuticagent is tolvaptan. In some embodiments, the multiple indicationsinclude hyponatremia. In some embodiments, the multiple indicationsincludes autosomal dominant polycystic kidney disease (ADPKD). In otherembodiments, the therapeutic agent can be any other suitable therapeuticagent and/or a first indication and/or a second indication can be anyother suitable indications associated with that therapeutic agent.

At 910, a request is received (e.g., by the dispenser module 128) from acompute device associated with a pharmacy (e.g., the dispenser 116)enrolled in the RMS to dispense the therapeutic agent to a patient. Insome embodiments, the request includes an identifier of a firstindication associated with the therapeutic agent. In other embodiments,the request can include an identifier associated with the patient andthe RMS can identify the first indication based on analyzing a profileof the patient in the RMS and identified by the identifier associatedwith the patient.

At 920A, it is determined if the request meets the dispensationcriterion for the first indication. If this is found to be the case, afirst authorization code is generated at 930. At 940, the firstauthorization code is provided to the dispenser 116 (e.g., sent to acompute device of the pharmacy via a network, telephonically, and/or thelike), such that the pharmacy/dispenser can use the authorization codeto dispense the therapeutic agent to the patient.

If the request does not meet the dispensation criterion for the firstindication at 920A, at 920B, it is determined (e.g., by theauthorization module 130) if the request meets a dispensation criterionassociated with a second indication. If this is found to be the case, asecond authorization code is generated at 950. At 960, the secondauthorization code is provided to the dispenser 116 (e.g., sent to acompute device of the pharmacy via a network, telephonically, and/or thelike), such that the pharmacy/dispenser can use the authorization codeto dispense the therapeutic agent to the patient for the firstindication. In some embodiments, at 990, if the request does not meetthe dispensation criterion associated with a second indication at 920B,the pharmacy is not authorized to dispense the therapeutic agent to thepatient. This can be communicated to the pharmacy and/or patient in anysuitable manner including, for example, not responding to the request,generating a code indicative of the request not meeting the dispensationcriterion, and/or the like. In some embodiments, if the conditions ofstep 920A are satisfied, then step 920B and its subsequent steps are notexecuted, and vice versa, i.e., if the conditions of step 920B aresatisfied, then step 920A and its subsequent steps are not executed.

In some embodiments, the dispensation criterion associated with thesecond indication includes a confirmation of a diagnostic test conductedon the patient and associated with the therapeutic agent. In someembodiments, for example, the diagnostic test is an LFT. In someembodiments, for example, the first indication is hyponatremia and thesecond indication is autosomal dominant polycystic kidney disease(ADPKD). The dispensation criterion can include any suitablerequirement(s) that the request must satisfy to authorize the patient toreceive the therapeutic agent including, but not limited to, whether thepatient has undergone a diagnostic test, whether the request is for anamount/number of doses/dosage strength that is appropriate for thepatient's indication, and/or the like. In this manner, a therapeuticagent can be dispensed for a first indication if the requirement fordispensing the drug for a second indication are met. In someembodiments, the dispensation criterion for the second indication can begreater/more stringent than that for the first indication, and places agreater demand on the patient if he/she wishes to acquire thetherapeutic agent in the instance of not meeting the dispensationcriterion for his/her indication.

Explained with reference to FIG. 1, FIG. 10 illustrates a method 1000 ofauthorizing a patient, such as the patient 114, to receive a therapeuticagent for an indication, if certain dispensation criteria and/orenrollment criteria are met for that indication. In some embodiments,the patient can be enrolling in RMS for the first time. In otherembodiments, the patient can be reenrolling in the RMS and/or obtaininga refill of the therapeutic agent. In some embodiments, the therapeuticagent is tolvaptan. In some embodiments, the indication is one ofmultiple indications associated with the therapeutic agent. In someembodiments, the multiple indications includes hyponatremia. In someembodiments, the multiple indications includes autosomal dominantpolycystic kidney disease (ADPKD).

At 1010, a request to dispense a quantity of the therapeutic agent to apatient is received (e.g., by the dispenser module 128) from a computedevice associated with a pharmacy enrolled in the RMS (e.g., thedispenser 116). The request can include a specification and/oridentifier associated with an indication from the multiple indications.The request can also include an indication of the quantity/form oftherapeutic agent to dispense (e.g., the dosage, whether intablet/capsule/liquid form, number of units, etc.). In otherembodiments, the request can include an identifier associated with thepatient and the RMS can identify the indication and/or the quantity/formof the therapeutic agent based on analyzing a profile of the patient inthe RMS and identified by the identifier associated with the patient.

At 1020A, it is determined (e.g., by the RMS device 100) if (1) theindication in the request is a first indication from the multipleindications, and (2) the quantity meets a dispensation criterionassociated with the therapeutic agent for the first indication. If thisis found to be the case, a first authorization code is generated at1030. At 1040, the first authorization code is provided to the computedevice associated with the pharmacy (e.g., sent to a compute device ofthe pharmacy via a network, telephonically, and/or the like).

In some embodiments, the first indication is hyponatremia, and thedispensation criterion associated with the first indication includes atleast one of: an indication of diagnosis of hyponatremia; a date ofhospitalization of the patient; a date of initiation of treatment withthe therapeutic agent; a daily dose of the treatment with thetherapeutic agent; or an indication of the patient's serum sodiumconcentration. In some embodiments, the first indication ishyponatremia, the therapeutic agent is Tolvaptan, and the dispensationcriterion associated with the therapeutic agent for the first indicationcan be, for example, between 15 mg daily to 60 mg daily. For example,the dispensation criterion can be from about 15 mg daily, about 20 mgdaily, about 30 mg daily, about 40 mg daily, about 50 mg daily, about 55mg daily, and/or about 60 mg daily, including values and/or sub-rangesin-between. In other embodiments, the dispensation criterion associatedwith the first indication can be any other suitable dose, such as, forexample, less than 15 mg daily or greater than 60 mg daily. In someembodiments, the dispensation criterion associated with the therapeuticagent for the first indication can be, for example, between 5 mg dosesto 45 mg doses. For example, the dispensation criterion for the firstindication can be based on about 5 mg doses of the therapeutic agent,about 10 mg doses, about 15 mg doses, about 20 mg doses, about 25 mgdoses, about 30 mg doses, about 35 mg doses, about 40 mg doses, and/orabout 45 mg doses, combinations thereof, and/or values in between. Inother embodiments, the dispensation criterion associated with the firstindication can be any other suitable dose amount, such as, for example,less than 5 mg doses or greater than 45 mg doses.

If the conditions of step 1020A are not met, at 1020B, it is determinedif (1) the indication in the request is a second indication from themultiple indications, and (2) (3) the quantity meets a dispensationcriterion associated with the therapeutic agent for the secondindication. If this is found to be the case, a second authorization codeis generated at 1060. In some embodiments, if the conditions of step1020A are satisfied, then step 1020B and its subsequent steps are notexecuted, and vice versa, i.e., if the conditions of step 1020B aresatisfied, then step 1020A and its subsequent steps are not executed.

In some embodiments, at 1090, if the request does not meet the criterionof 1020A or 1020B, t the pharmacy is not authorized to dispense thetherapeutic agent to the patient. This can be communicated to thepharmacy and/or patient in any suitable manner including, for example,not responding to the request, generating a code indicative of therequest not meeting the dispensation criterion, and/or the like.

In some embodiments (not shown), step 1020A can further includes thedetermination whether the request meets a patient enrollment criterionassociated with the first indication; if this is the case, and if otheraspects of step 1020A are also satisfied, the patient can be enrolled inthe RMS for a first duration associated with the first indication.

In some embodiments (not shown), step 1020B can further includes thedetermination whether the request meets a patient enrollment criterionassociated with the second indication; if this is the case, and if otheraspects of step 1020B are also satisfied, the patient can be enrolled inthe RMS for a second duration (which can be different than the firstindication) associated with the second indication.

In some embodiments, the second indication is autosomal dominantpolycystic kidney disease (ADPKD), and the dispensation criterionassociated with the second indication includes an indication ofdiagnosis of ADPKD, and a confirmation of a diagnostic test conducted onthe patient and associated with the therapeutic agent. In someembodiments, the diagnostic test is a LFT. In some embodiments, thesecond indication is autosomal dominant polycystic kidney disease(ADPKD), the therapeutic agent is Tolvaptan, and the dispensationcriterion associated with the therapeutic agent for the secondindication can be, for example, between a 15 mg dose to a 120 mg dose.For example, the dispensation criterion can be a 15 mg dose, a 20 mgdose, a 30 mg dose, a 40 mg dose, a 50 mg dose, a 60 mg dose, a 70 mgdose, a 80 mg dose, a 90 mg dose, a 100 mg dose, and/or a 120 mg dose,combinations thereof, including all sub values. In other embodiments,the dose can be any other suitable dose, for example, below 15 mg orabove 120 mg. At 1070, the second authorization code is provided to thecompute device associated with the pharmacy (e.g., sent to a computedevice of the pharmacy via a network, telephonically, and/or the like).

In some embodiments, if (1) the indication is a first indication fromthe multiple indications, (2) the quantity does not meets a dispensationcriterion associated with the therapeutic agent for the firstindication, and (3) the quantity meets a dispensation criterionassociated with the therapeutic agent for the second indication, themethod 1000 can further include generating a warning code, such as, forexample, at step 1090. In this manner, the pharmacy/dispenser can bewarned that the patient is requesting a quantity presribable for adifferent indication.

While various embodiments have been described herein, it should beunderstood that they have been presented by way of example, and notlimitation. Where methods described above indicate certain eventsoccurring in certain order, the ordering of certain events may bemodified. Additionally, certain of the events may be performedconcurrently in a parallel process when possible, as well as performedsequentially as described herein.

Although some of the modules are described as providing interfaces forinteracting with the prescriber 112, the patient 114, the dispenser 116,and/or other users of the RMS host device 100, it is understood that insome embodiments, some or all such interactions may be enabled via anintegrated portal usable by each of these entities. In such embodiments,each entity interacting with the portal can have an account and/or beotherwise registered with the host device 100. In some embodiments, theregistration can be linked and/or included in profile information of theentity. For example, the registration of the prescriber 112 can belinked to the prescriber profile for that particular prescriber. Asanother example, the registration of a pharmacy (i.e., a dispenser)and/or one or more pharmacists for the pharmacy can be linked to thedispenser profile for the pharmacy.

Although not described in detail here, the host device 100 can includeadditional modules and/or functionality for interacting with otherentities such as insurance providers, diagnostic testing laboratories,distribution vendors, and/or the like. For example, an insuranceprovider can require confirmation of a successful diagnostic test beforereimbursing the patient and/or the dispenser for the therapeutic agent.As another example, the prescriber can directly order diagnostic testsfor the patient at the diagnostic testing laboratory via the host device100. As yet another example, a distribution vendor responsible fordelivering the therapeutic agent to a vendor can check if the vendor isenrolled at the host device 100, can receive notifications whenever adispenser is enrolled/un-enrolled at the host device, and/or the like.

Although the prescription for the therapeutic agent is described asbeing provided by the prescriber to the patient, in other embodiments,the prescription information is additionally or alternatively includedin the patient enrollment form by the prescriber. In such embodiments,the host device 100 can perform additional checks to ensure the patientis receiving the prescribed dose. For example, in the embodiment of FIG.5, the first or second authorization code would only be generated if thehost device determines the patient has not exhausted his prescription.If the prescription permitted five refills, the patient would be unableto obtain a sixth refill even if a successful diagnostic test had beenconfirmed in a timely manner by the prescriber (e.g., within the firstpredetermined time period), since the host device would generate thethird authorization code, forbidding the pharmacy from dispensing thetherapeutic agent to the patient. While a trained pharmacist and stateof the art pharmacy systems would typically catch such an oversight,such aspects of the host device 100 can provide an additional layer ofsecurity against oversight and/or potential abuse.

In some embodiments, the patient visits the dispenser for the first timethe therapeutic agent is dispensed to the patient, and the prescribedrefills can be provided to the patient thereafter by the dispenserwithout any further action on the patient's part. For example, thedispenser can, prior to when the patient is expected to run out of thelast dispensed quantity of the therapeutic agent, submit anauthorization request to the host device 100 as described earlier. Inthis manner, the dispenser can verify the patient is authorized tocontinue receiving the therapeutic agent, and mail the refill of thetherapeutic agent to the patient in a timely manner.

In some embodiments, a method includes receiving, at a host device of arisk management system (RMS) for a therapeutic agent associated with atleast one indication, from a prescriber, a request to enroll theprescriber in the RMS. The method also includes providing, to theprescriber, educational material associated with the RMS and associatedwith the therapeutic agent. The method further includes providing, tothe prescriber, access to a test relating to the educational material,and receiving, at the host device, an identifier of a performance of theprescriber on the test. The method also includes enrolling, at the hostdevice, the prescriber in the RMS if the performance of the prescribermeets a performance criterion for the test.

In some embodiments, the therapeutic agent is tolvaptan. In someembodiments, the at least one indication includes hyponatremia. In someembodiments, the at least one indication includes autosomal dominantpolycystic kidney disease (ADPKD). In some embodiments, the enrollingincludes authorizing the prescriber to prescribe the therapeutic agent.

In some embodiments, enrolling the prescriber can include enrolling theprescriber for a predetermined time period. In some embodiments, themethod can further include providing, after the enrolling and to theprescriber, prior to lapse of the predetermined time period,reenrollment information associated with the RMS and with thetherapeutic agent. The method can also include receiving consent fromthe prescriber in response to the reenrollment information, andreenrolling, at the host device, the prescriber in the RMS in responseto receiving the consent.

In some embodiments, the therapeutic agent is associated with multipleindications.

In some embodiments, another method includes receiving, at a host deviceof a risk management system (RMS) for a therapeutic agent associatedwith at least one indication, from a pharmacy, a request to enroll thepharmacy in the RMS. The method also includes providing, to a pharmacistassociated with the pharmacy, educational material associated with theRMS and with the therapeutic agent. The method also includes providing,to the pharmacist, access to a test relating to the educationalmaterial. The method further includes receiving, at the host device, anidentifier of a performance of the pharmacist on the test. The methodalso includes enrolling, at the host device, the pharmacy in the RMS ifthe performance of the pharmacist meets a performance criterion for thetest.

In some embodiments, the therapeutic agent includes tolvaptan. In someembodiments, the at least one indication includes hyponatremia. In someembodiments, the at least one indication includes autosomal dominantpolycystic kidney disease (ADPKD). In some embodiments, the enrollingincludes authorizing the pharmacy to dispense the therapeutic agent.

In some embodiments, the enrolling includes enrolling the pharmacy for apredetermined time period. In some embodiments, the method can furtherinclude providing, after the enrolling and to the pharmacist prior tolapse of the predetermined time period, reenrollment informationassociated with the RMS and with the therapeutic agent. The method canalso include receiving consent from the pharmacist in response to thereenrollment information, and reenrolling, at the host device, thepharmacist in the RMS in response to receiving the consent.

In some embodiments, another method includes receiving, at a host deviceof a risk management system (RMS) for a therapeutic agent associatedwith at least one indication, a confirmation of a diagnostic test of apatient enrolled in the RMS by a prescriber enrolled with the RMS. Themethod also includes, based on the receipt of the confirmation from theprescriber, generating a code indicating whether a pharmacy enrolled inthe RMS is authorized to dispense the therapeutic agent to the patient.The method also includes receiving, at the host device and from acompute device associated with the pharmacy, a request to dispense thetherapeutic agent to the patient. The method also includes providing theauthorization code to the compute device associated with the pharmacy.

In some embodiments, the confirmation includes an identifier of a dateon which the diagnostic test was performed on the patient. In someembodiments, generating the code includes generating the code if therequest is received within a predetermined time period from the date.

In some embodiments, the method can further include transmitting, fromthe host device to the prescriber, a request for the confirmation of thediagnostic test. The confirmation can be received in response to therequest for the confirmation.

In some embodiments, the therapeutic agent includes tolvaptan. In someembodiments, the at least one indication includes hyponatremia. In someembodiments, the at least one indication includes autosomal dominantpolycystic kidney disease (ADPKD).

In some embodiments, the method can further include verifying that atleast one of the pharmacy or a pharmacist associated with the pharmacyis enrolled in the RMS prior to providing the authorization code. Insome embodiments, the confirmation can include confirmation of asuccessful diagnostic test. In such embodiments, the code authorizes thepharmacy to dispense the therapeutic agent to the patient.

In some embodiments, the method can further include re-enrolling thepatient in the RMS based on the successful diagnostic test.

In some embodiments, the confirmation includes confirmation of at leastone of an unsuccessful diagnostic test or an adverse event associatedwith the patient using the therapeutic agent. In such embodiments, theauthorization code prohibits the pharmacy from dispensing thetherapeutic agent to the patient. In some embodiments, the adverse eventis associated with one or more side effects associated with the at leastone indication. In some embodiments, the method can further includeverifying an enrollment status of the prescriber prior to thegenerating.

In some embodiments, another method includes receiving, at a host deviceof a risk management system (RMS) for a therapeutic agent associatedwith at least one indication, a request from a pharmacy enrolled in theRMS to dispense a first quantity of the therapeutic agent to a patientenrolled in the RMS. The method further includes generating a firstauthorization code if a confirmation of a successful diagnostic test ofthe patient was received from a prescriber enrolled in the RMS within afirst predetermined time period. The method also includes generating asecond authorization code if: the confirmation of the successfuldiagnostic test of the patient was not received within the firstpredetermined time period, and the request from the compute deviceassociated with the pharmacy is received within a second predeterminedtime period; or a request is received from a compute device associatedwith the prescriber to dispense a second quantity of the therapeuticagent to the patient, the second quantity different from the firstquantity; or both. The method also includes generating a thirdauthorization code if the confirmation of the successful diagnostic testof the patient was not received within the first predetermined timeperiod and if the request from the compute device associated with theprescriber to dispense the second quantity of the therapeutic agent isnot received. The method also includes providing the first authorizationcode, the second authorization code, or the third authorization code tothe compute device associated with the pharmacy.

In some embodiments, the therapeutic agent includes tolvaptan. In someembodiments, the at least one indication includes hyponatremia. In someembodiments, the at least one indication includes autosomal dominantpolycystic kidney disease (ADPKD).

In some embodiments, the first authorization code authorizes thepharmacy to dispense the first quantity of the therapeutic agent to thepatient, the first quantity being a standard quantity. In someembodiments, the second authorization code authorizes the pharmacy todispense the second quantity of the therapeutic agent to the patientwithout the confirmation of the successful diagnostic test. In someembodiments, the third authorization code prohibits the pharmacy fromdispensing the therapeutic agent to the patient.

In some embodiments, the method can further include transmitting, fromthe host device to the prescriber, a request for the confirmation of thesuccessful diagnostic test. In such embodiments, the confirmation isreceived in response to the request for the confirmation.

In some embodiments, another method includes receiving, at a host deviceof a risk management system (RMS) for a therapeutic agent associatedwith multiple indications, from a prescriber, a request to enroll apatient in the RMS. The request includes a specification of at least oneindication, and a confirmation of a diagnostic test conducted on thepatient. The diagnostic test is associated with the therapeutic agentand is associated with the a indication. The method can also includeenrolling, at the host device, in response to the request, the patientin the RMS. Enrolling the patient includes identifying a predeterminedenrollment period based on the indication. The predetermined enrollmentperiod has a first duration when the indication is a first indication,and has a second duration different from the first duration when theindication is a second indication. The enrolling also includes, based onthe predetermined enrollment period, generating an authorization codeindicating whether the patient is authorized to receive the therapeuticagent.

In some embodiments, the method can further include receiving a requestto dispense a refill of the therapeutic agent to the patient. The methodcan also include generating a new authorization code indicating whetherthe patient is authorized to receive a refill of the therapeutic agentusing (1) a first process if the at least one indication is the firstindication or (2) a second process different from the first process ifthe at least one indication is the second indication.

In some embodiments, the diagnostic test is a first diagnostic test. Insome embodiments, the at least one indication is the first indication,and the method can further include generating the new authorization codein response to receiving, at the host device and from the prescriber, aconfirmation of a second diagnostic test within the predeterminedenrollment period. In some embodiments, the at least one indication isthe second indication, and the method can further include generating thenew authorization code in response to receiving a request within thepredetermined enrollment period and without receiving the confirmationof the second diagnostic test.

In some embodiments, the method can further include providing, after theenrolling and to the prescriber, prior to lapse of the predeterminedenrollment period, patient reenrollment information associated with: (1)the RMS, (2) the therapeutic agent, and (3) the first indication. Themethod can also include receiving consent from the prescriber and thepatient in response to the patient reenrollment information, andreenrolling, at the host device, the patient in the RMS in response toreceiving the consent.

In some embodiments, the method can further include receiving, at thehost device, for the therapeutic agent, from a prescriber, a request toenroll the prescriber in the RMS. The method can also include providing,to the prescriber, educational material associated with the RMS andassociated with the therapeutic agent. The method can also includeproviding, to the prescriber, access to a test relating to theeducational material, and receiving, at the host device, an identifierof a performance of the prescriber on the test. The method can alsoinclude enrolling, at the host device, the prescriber in the RMS if theperformance of the prescriber meets a performance criterion for thetest.

In some embodiments, the method can also include receiving, at the hostdevice, for the therapeutic agent, from a pharmacy, a request to enrollthe pharmacy in the RMS. The method can further include providing, to apharmacist associated with the pharmacy, educational material associatedwith the RMS and with the therapeutic agent. The method can also includeproviding, to the pharmacist, access to a test relating to theeducational material, and receiving, at the host device, an identifierof a performance of the pharmacist on the test. The method can alsoinclude enrolling, at the host device, the pharmacy in the RMS if theperformance of the pharmacist meets a performance criterion for thetest.

Some embodiments described herein relate to a computer storage productwith a non-transitory computer-readable medium (also can be referred toas a non-transitory processor-readable medium) having instructions orcomputer code thereon for performing various computer-implementedoperations. The computer-readable medium (or processor-readable medium)is non-transitory in the sense that it does not include transitorypropagating signals per se (e.g., a propagating electromagnetic wavecarrying information on a transmission medium such as space or a cable).The media and computer code (also can be referred to as code) may bethose designed and constructed for the specific purpose or purposes.Examples of non-transitory computer-readable media include, but are notlimited to: magnetic storage media such as hard disks, floppy disks, andmagnetic tape; optical storage media such as Compact Disc/Digital VideoDiscs (CD/DVDs), Compact Disc-Read Only Memories (CD-ROMs), andholographic devices; magneto-optical storage media such as opticaldisks; carrier wave signal processing modules; and hardware devices thatare specially configured to store and execute program code, such asApplication-Specific Integrated Circuits (ASICs), Programmable LogicDevices (PLDs), Read-Only Memory (ROM) and Random-Access Memory (RAM)devices. Other embodiments described herein relate to a computer programproduct, which can include, for example, the instructions and/orcomputer code discussed herein.

Examples of computer code include, but are not limited to, micro-code ormicro-instructions, machine instructions, such as produced by acompiler, code used to produce a web service, and files containinghigher-level instructions that are executed by a computer using aninterpreter. For example, embodiments may be implemented usingimperative programming languages (e.g., C, Fortran, etc.), functionalprogramming languages (Haskell, Erlang, etc.), logical programminglanguages (e.g., Prolog), object-oriented programming languages (e.g.,Java, C++, etc.) or other suitable programming languages and/ordevelopment tools. Additional examples of computer code include, but arenot limited to, control signals, encrypted code, and compressed code.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example, and notlimitation. Where methods described above indicate certain eventsoccurring in certain order, the ordering of certain events can bemodified. Additionally, certain of the events may be performedconcurrently in a parallel process when possible, as well as performedsequentially as described above.

What is claimed is:
 1. A risk management system (RMS) device,comprising: an RMS database; and an RMS processor, the RMS processorconfigured to receive, via a communication network and from a computedevice associated with a prescriber, a request to enroll a patient in anRMS program of a therapeutic agent associated with a plurality ofindications, the request including: a specification of at least oneindication from the plurality of indications; and a confirmation of adiagnostic test conducted on the patient, the diagnostic test associatedwith the therapeutic agent and associated with the at least oneindication from the plurality of indications, the RMS processor furtherconfigured, in response to the request, to identify a predeterminedenrollment period based on the at least one indication from theplurality of indications and to generate a patient profile, the patientprofile including the predetermined enrollment period, the predeterminedenrollment period having a first duration when the at least oneindication is a first indication from the plurality of indications, thepredetermined enrollment period having a second duration different fromthe first duration when the at least one indication is a secondindication from the plurality of indications; the RMS processorconfigured to store the patient profile in the RMS database; the RMSprocessor configured to generate a first authorization code, based onthe predetermined enrollment period, authorizing a pharmacy or theprescriber to dispense the therapeutic agent to the patient and togenerate a plurality of additional authorization codes, each additionalauthorization code from the plurality of additional authorization codesincluding an initial default instruction prohibiting the pharmacy or theprescriber from dispensing the therapeutic agent, the RMS processorconfigured to associate the first authorization code and the pluralityof additional authorization codes with the patient profile; and the RMSprocessor configured to transmit via the communication network the firstauthorization code to at least one of a compute device associated withthe pharmacy or the compute device associated with the prescriber suchthat the therapeutic agent can be dispensed to the patient based on thefirst authorization code, the RMS processor configured to transmit eachadditional authorization code from the plurality of additionalauthorization codes and including the initial default instruction viathe communication network to at least one of the compute deviceassociated with the pharmacy or the compute device associated with theprescriber such that the pharmacy or the prescriber is prohibited fromdispensing the therapeutic agent based on the plurality of additionalauthorization codes for a time period after receiving each additionalauthorization code including the initial default instruction.
 2. The RMSdevice of claim 1, wherein the RMS processor is further configured to:receive, for the therapeutic agent, from the compute device associatedwith the pharmacy, a request to enroll the pharmacy in the RMS program;transmit, to the compute device associated with the pharmacy,educational material associated with the RMS and the therapeutic agent;transmit, to the compute device associated with the pharmacy, access toa test relating to the educational material for a user of the computedevice associated with the pharmacy; receive an identifier of aperformance of the user of the compute device associated with thepharmacy on the test; and generate a dispenser profile for the pharmacyif the identifier of the performance meets a performance criterion forthe test, the RMS processor further configured to store the dispenserprofile in the RMS database as a new dispenser profile.
 3. The RMSdevice of claim 1, wherein the RMS processor is further configured to:generate, prior to lapse of the predetermined enrollment period, andafter generating the patient profile, patient reenrollment informationassociated with: (1) the RMS program, (2) the therapeutic agent, and (3)the first indication; transmit the patient reenrollment information tothe compute device associated with the prescriber; and receive anindication of consent from the compute device associated with theprescriber in response to the patient reenrollment information, the RMSprocessor further configured to update the patient profile in the RMSdatabase in response to receiving the consent.
 4. The RMS device ofclaim 1, wherein the RMS processor is configured to modify at least oneadditional authorization code from the plurality of additionalauthorization codes based on an event subsequent to the generation ofthe plurality of additional authorization codes such the at least oneadditional authorization code authorizes the pharmacy or the prescriberto dispense the therapeutic agent to the patient, the event including atleast one of: a receipt of a diagnostic test result, a receipt of anadverse event report, or a receipt of a dispensing request.
 5. Themethod of claim 1, wherein the time period is a period of time betweenreceipt of each additional authorization code including the initialdefault instruction and receipt of an additional authorization code thathas been modified by the RMS processor such that the additionalauthorization code authorizes the pharmacy or the prescriber to dispensethe therapeutic agent to the patient.
 6. A risk management system (RMS)device, comprising: a RMS database storing dispenser profiles, patientprofiles, and prescriber profiles; and a RMS processor, the RMSprocessor configured to receive, for a therapeutic agent associated witha plurality of indications, a request from a compute device associatedwith a pharmacy to dispense a first quantity of the therapeutic agent toa patient, the RMS database including a dispenser profile for thepharmacy, the RMS database including a patient profile for the patient;the RMS processor configured to receive a confirmation of a successfuldiagnostic test of the patient from a compute device associated with aprescriber, the RMS database including a prescriber profile for theprescriber; the RMS processor configured to generate a firstauthorization code if the successful diagnostic test of the patient isassociated with at least one indication from the plurality ofindications and the confirmation of the successful diagnostic test ofthe patient was received within a first predetermined time period, theRMS processor further configured to generate a second authorization codeif at least one of: (1) the successful diagnostic test of the patient isassociated with the at least one indication, the confirmation of thesuccessful diagnostic test of the patient was not received within thefirst predetermined time period, and the request from the compute deviceassociated with the pharmacy is received within a second predeterminedtime period, or (2) a request is received from the compute deviceassociated with the prescriber to dispense a second quantity of thetherapeutic agent to the patient, the second quantity different from thefirst quantity, the RMS processor further configured to generate a thirdauthorization code if: (1) the confirmation of the successful diagnostictest of the patient is not associated with the at least one indicationor the confirmation of the successful diagnostic test of the patient wasnot received within the first predetermined time period, or (2) therequest from the compute device associated with the prescriber todispense the second quantity of the therapeutic agent is not receivedwithin a third predetermined time period; and the RMS processorconfigured to transmit the first authorization code, the secondauthorization code, or the third authorization code to the computedevice associated with the pharmacy such that the pharmacy is permittedto dispense the first quantity of the therapeutic agent if the computedevice associated with the pharmacy receives the first authorizationcode, the pharmacy is permitted to dispense the second quantity of thetherapeutic agent if the compute device associated with the pharmacyreceives the second authorization code, and the pharmacy is prohibitedfrom dispensing the first quantity and the second quantity if thecompute device associated with the pharmacy receives the thirdauthorization code.
 7. The RMS device of claim 6, wherein the at leastone indication includes at least one of hyponatremia or autosomaldominant polycystic kidney disease (ADPKD).
 8. A method, comprising:receiving, at a host device of a risk management system (RMS) for atherapeutic agent associated with a plurality of indications, from acompute device associated with a prescriber, a request to enroll theprescriber in the RMS; enrolling, at the host device, the prescriber inthe RMS if the performance of the prescriber meets a performancecriterion for the test, receiving, at the host device, from a computedevice associated with the prescriber, a request to enroll a patient inthe RMS, the request including a specification of at least oneindication from the plurality of indications and a confirmation of adiagnostic test conducted on the patient, the diagnostic test associatedwith the therapeutic agent and associated with the at least oneindication from the plurality of indications; identifying, in responseto receiving the request, a predetermined enrollment period based on theat least one indication from the plurality of indications, thepredetermined enrollment period having a first duration when the atleast one indication is a first indication from the plurality ofindications, the predetermined enrollment period having a secondduration different from the first duration when the at least oneindication is a second indication from the plurality of indications;generating a first authorization code based on the predeterminedenrollment period authorizing a pharmacy or the prescriber to dispensethe therapeutic agent to the patient; generating a plurality ofadditional authorization codes, each additional authorization code fromthe plurality of authorization codes including an initial defaultinstruction prohibiting the pharmacy or the prescriber from dispensingthe therapeutic agent, associating the first authorization code and theplurality of additional authorization codes with a patient profile; andtransmitting the first authorization code at least one of a computedevice associated with the pharmacy or the compute device associatedwith the prescriber such that the therapeutic agent can be dispensed tothe patient based on the first authorization code.
 9. The method ofclaim 8, wherein the enrolling includes authorizing the prescriber toprescribe the therapeutic agent.
 10. The method of claim 8, wherein theenrolling includes enrolling the prescriber for a predetermined timeperiod, the method further comprising: providing, after the enrollingand to the prescriber, prior to lapse of the predetermined time period,reenrollment information associated with the RMS and with thetherapeutic agent; receiving consent from the prescriber in response tothe reenrollment information; and reenrolling, at the host device, theprescriber in the RMS in response to receiving the consent.
 11. Amethod, comprising: receiving, at a host device of a risk managementsystem (RMS) for a therapeutic agent associated with a plurality ofindications, a request from a compute device associated with a pharmacyenrolled in the RMS to dispense a first quantity of the therapeuticagent to a patient enrolled in the RMS, the request including aspecification of at least one indication from the plurality ofindications; generating a first authorization code if a confirmation ofa successful diagnostic test of the patient was received from aprescriber enrolled in the RMS within a first predetermined time period,the successful diagnostic test associated with the at least oneindication from the plurality of indications, the first authorizationcode authorizing the pharmacy to dispense the first quantity of thetherapeutic agent to the patient; generating a second authorization codeif at least one of: (1) the confirmation of the successful diagnostictest of the patient was not received within the first predetermined timeperiod, and the request from the compute device associated with thepharmacy is received within a second predetermined time period; or (2) arequest is received from a compute device associated with the prescriberto dispense a second quantity of the therapeutic agent to the patient,the second quantity different from the first quantity, the secondauthorization code authorizing the pharmacy to dispense the secondquantity to the patient; generating a third authorization code if theconfirmation of the successful diagnostic test of the patient was notreceived within the first predetermined time period and if the requestfrom the compute device associated with the prescriber to dispense thesecond quantity of the therapeutic agent is not received within a thirdpredetermined time period, the third authorization code prohibiting thepharmacy from dispensing the therapeutic agent to the patient; andproviding the first authorization code, the second authorization code,or the third authorization code to the compute device associated withthe pharmacy.
 12. The method of claim 11, wherein the first quantity isa standard quantity.
 13. The method of claim 11, wherein the secondauthorization code authorizes the pharmacy to dispense the secondquantity of the therapeutic agent to the patient without theconfirmation of the successful diagnostic test.
 14. The method of claim11, further comprising transmitting, from the host device to theprescriber, a request for the confirmation of the successful diagnostictest, the confirmation received in response to the request for theconfirmation.
 15. The method of claim 11, further comprising: receiving,at the host device of the RMS, the confirmation of the successfuldiagnostic test, the confirmation of the successful diagnostic testassociated with a patient test result meeting a dispensation criterionfor the at least one indication from the plurality of indications. 16.The method of claim 11, further comprising: conducting a diagnostic testassociated with the at least one indication from the plurality ofindications to determine whether the diagnostic test is successful basedon whether a patient test result meets a dispensation criterion for theat least one indication from the plurality of indications; and sendingthe confirmation of the successful diagnostic test of the patient to thehost device of the RMS if the patient test result meets the dispensationcriterion.